Local Phase 4 Pan-European SMART Study
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- Number of Severe Asthma Exacerbations Per Participant. [6 months]
Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Secondary Outcome Measures
- Fraction of Participants With Severe Asthma Exacerbation [6 months.]
The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
- Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. [6 months.]
A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant
- Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation [6 months.]
Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
- Mean Daily Number of Inhalations of As-needed Medication. [4 weeks]
The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.
- Percent of Participants With a Well Controlled Asthma Week. [6 months.]
The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.
- Mean Overall Asthma Control Questionnaire (ACQ) Score [6 months.]
The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.
- The Mean Total Daily Dose of Steroids From Symbicort. [4 weeks]
The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.
- Mean Cost Per Participant Per Country [6 months]
Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients at out-patient clinics
-
18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief
Exclusion Criteria:
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Asthma exacerbation within the last 14 days prior to study start
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subject aged >40 years with a smoking history of >10pack-years
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subjects with chronic obstructive lung disease or other significant respiratory disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Research Site | Aalst | Belgium | ||
2 | Research Site | Aarschot | Belgium | ||
3 | Research Site | Aatrijken | Belgium | ||
4 | Research Site | Asse | Belgium | ||
5 | Research Site | Balen | Belgium | ||
6 | Research Site | Bastogne | Belgium | ||
7 | Research Site | Bellaire | Belgium | ||
8 | Research Site | Betrix | Belgium | ||
9 | Research Site | Binche | Belgium | ||
10 | Research Site | Blankenberge | Belgium | ||
11 | Research Site | Boortmeerbeek | Belgium | ||
12 | Research Site | Bornem | Belgium | ||
13 | Research Site | Boussu | Belgium | ||
14 | Research Site | Brugge | Belgium | ||
15 | Research Site | Bruxelles | Belgium | ||
16 | Research Site | Buizingen | Belgium | ||
17 | Research Site | Burdinne | Belgium | ||
18 | Research Site | Champion | Belgium | ||
19 | Research Site | Charleroi | Belgium | ||
20 | Research Site | Chatelet | Belgium | ||
21 | Research Site | Chenee | Belgium | ||
22 | Research Site | Dendermonde | Belgium | ||
23 | Research Site | Diksmuide | Belgium | ||
24 | Research Site | Drongen | Belgium | ||
25 | Research Site | Duffel | Belgium | ||
26 | Research Site | Edegem | Belgium | ||
27 | Research Site | Eeklo | Belgium | ||
28 | Research Site | Ekeren | Belgium | ||
29 | Research Site | Erembodegem | Belgium | ||
30 | Research Site | Evergem | Belgium | ||
31 | Research Site | Fleurus | Belgium | ||
32 | Research Site | Gembloux | Belgium | ||
33 | Research Site | Genk | Belgium | ||
34 | Research Site | Gent | Belgium | ||
35 | Research Site | Gilly | Belgium | ||
36 | Research Site | Graty | Belgium | ||
37 | Research Site | Grivegnee | Belgium | ||
38 | Research Site | Halle | Belgium | ||
39 | Research Site | Ham-sur-Heure | Belgium | ||
40 | Research Site | Ham | Belgium | ||
41 | Research Site | Hasselt | Belgium | ||
42 | Research Site | Havinnes | Belgium | ||
43 | Research Site | Heist-op-Den-Berg | Belgium | ||
44 | Research Site | Herentals | Belgium | ||
45 | Research Site | Herstal | Belgium | ||
46 | Research Site | Hoboken | Belgium | ||
47 | Research Site | Hoeselt | Belgium | ||
48 | Research Site | Hooglede | Belgium | ||
49 | Research Site | Hornu | Belgium | ||
50 | Research Site | Houthalen-Helchteren | Belgium | ||
51 | Research Site | Huldenberg | Belgium | ||
52 | Research Site | Izegem | Belgium | ||
53 | Research Site | Jambes | Belgium | ||
54 | Research Site | Jodoigne | Belgium | ||
55 | Research Site | Kinrooi | Belgium | ||
56 | Research Site | Kontich | Belgium | ||
57 | Research Site | Kraainem | Belgium | ||
58 | Research Site | La Louviere | Belgium | ||
59 | Research Site | Langdorp | Belgium | ||
60 | Research Site | Lauwe | Belgium | ||
61 | Research Site | Leopoldsburg | Belgium | ||
62 | Research Site | Leuven | Belgium | ||
63 | Research Site | Liege | Belgium | ||
64 | Research Site | Lier | Belgium | ||
65 | Research Site | Lommel | Belgium | ||
66 | Research Site | Lovendegem | Belgium | ||
67 | Research Site | Malmedy | Belgium | ||
68 | Research Site | Marchovelette | Belgium | ||
69 | Research Site | Meelbeke | Belgium | ||
70 | Research Site | Moerkerke | Belgium | ||
71 | Research Site | Mol | Belgium | ||
72 | Research Site | Monceau-sur-Sambre | Belgium | ||
73 | Research Site | Mons | Belgium | ||
74 | Research Site | Montegnee | Belgium | ||
75 | Research Site | Moorsel | Belgium | ||
76 | Research Site | Mouscron | Belgium | ||
77 | Research Site | Namur | Belgium | ||
78 | Research Site | Natoye | Belgium | ||
79 | Research Site | Nijlen | Belgium | ||
80 | Research Site | Nivelles | Belgium | ||
81 | Research Site | Oedelem | Belgium | ||
82 | Research Site | Oostende | Belgium | ||
83 | Research Site | Oostkamp | Belgium | ||
84 | Research Site | Oppuurs | Belgium | ||
85 | Research Site | Oudenaarde | Belgium | ||
86 | Research Site | Paal | Belgium | ||
87 | Research Site | Peutie | Belgium | ||
88 | Research Site | Poederlee | Belgium | ||
89 | Research Site | Pulle | Belgium | ||
90 | Research Site | Rijkevorsel | Belgium | ||
91 | Research Site | Rixensart | Belgium | ||
92 | Research Site | Rotselaar | Belgium | ||
93 | Research Site | Roux | Belgium | ||
94 | Research Site | Sijsele | Belgium | ||
95 | Research Site | Sint-Genesius-Rode | Belgium | ||
96 | Research Site | Sint-Niklaas | Belgium | ||
97 | Research Site | St Katharina Lombeek | Belgium | ||
98 | Research Site | St-Vith | Belgium | ||
99 | Research Site | Steenokkerzeel | Belgium | ||
100 | Research Site | Stekene | Belgium | ||
101 | Research Site | Tavier | Belgium | ||
102 | Research Site | Thieusies | Belgium | ||
103 | Research Site | Tielt | Belgium | ||
104 | Research Site | Tienen | Belgium | ||
105 | Research Site | Tirlt | Belgium | ||
106 | Research Site | Tongeren | Belgium | ||
107 | Research Site | Tournai | Belgium | ||
108 | Research Site | Tremelo | Belgium | ||
109 | Research Site | Turhout | Belgium | ||
110 | Research Site | Vedrin | Belgium | ||
111 | Research Site | Villers-Poterie | Belgium | ||
112 | Research Site | Vilvoorde | Belgium | ||
113 | Research Site | Vosselaar | Belgium | ||
114 | Research Site | Wambeek | Belgium | ||
115 | Research Site | Waregem | Belgium | ||
116 | Research Site | Waterloo | Belgium | ||
117 | Research Site | Wetteren | Belgium | ||
118 | Research Site | Wijnegem | Belgium | ||
119 | Research Site | Willebroek | Belgium | ||
120 | Research Site | Wilsele | Belgium | ||
121 | Research Site | Zele | Belgium | ||
122 | Research Site | Zemst | Belgium | ||
123 | Research Site | Zoersel | Belgium | ||
124 | Research Site | Zottegem | Belgium | ||
125 | Research Site | Zwijnaarde | Belgium | ||
126 | Research Site | Espho | Finland | ||
127 | Research Site | Espoo | Finland | ||
128 | Research Site | Hameenlinna | Finland | ||
129 | Research Site | Harjavalta | Finland | ||
130 | Research Site | Helsinki | Finland | ||
131 | Research Site | Hyvinkaa | Finland | ||
132 | Research Site | Joensuu | Finland | ||
133 | Research Site | Jokioinen | Finland | ||
134 | Research Site | Kannus | Finland | ||
135 | Research Site | Kemi | Finland | ||
136 | Research Site | Kereva | Finland | ||
137 | Research Site | Kokkola | Finland | ||
138 | Research Site | Korpilahti | Finland | ||
139 | Research Site | Kotka | Finland | ||
140 | Research Site | Kouvola | Finland | ||
141 | Research Site | Kuopio | Finland | ||
142 | Research Site | Kuusankoski | Finland | ||
143 | Research Site | Lahti | Finland | ||
144 | Research Site | Lappeenranta | Finland | ||
145 | Research Site | Lapua | Finland | ||
146 | Research Site | Lathi | Finland | ||
147 | Research Site | Lempaala | Finland | ||
148 | Research Site | Lohja | Finland | ||
149 | Research Site | Mikkeli | Finland | ||
150 | Research Site | Muurame | Finland | ||
151 | Research Site | Nurmij�rvi | Finland | ||
152 | Research Site | Oulu | Finland | ||
153 | Research Site | Pello | Finland | ||
154 | Research Site | Pieksamaki | Finland | ||
155 | Research Site | Pietarsaari | Finland | ||
156 | Research Site | Pori | Finland | ||
157 | Research Site | Porvo | Finland | ||
158 | Research Site | Pudasj�rvi | Finland | ||
159 | Research Site | Pyhajoki | Finland | ||
160 | Research Site | Riihimaki | Finland | ||
161 | Research Site | Seinajoki | Finland | ||
162 | Research Site | Suonenjoki | Finland | ||
163 | Research Site | Tamepare | Finland | ||
164 | Research Site | Tampera | Finland | ||
165 | Research Site | Turku | Finland | ||
166 | Research Site | Ulvila | Finland | ||
167 | Research Site | Vaajakoksi | Finland | ||
168 | Research Site | Vantaa | Finland | ||
169 | Research Site | Agen | France | ||
170 | Research Site | Aix En Provence | France | ||
171 | Research Site | Ajaccio | France | ||
172 | Research Site | Ales | France | ||
173 | Research Site | Amboise | France | ||
174 | Research Site | Amelie Les Bains Palalda | France | ||
175 | Research Site | Amiens | France | ||
176 | Research Site | Angers | France | ||
177 | Research Site | Angouleme | France | ||
178 | Research Site | Annecy | France | ||
179 | Research Site | Annonay | France | ||
180 | Research Site | Antibes Cedex | France | ||
181 | Research Site | Arpajon | France | ||
182 | Research Site | Asnieres Sur seine | France | ||
183 | Research Site | Aubagne Cedex | France | ||
184 | Research Site | Aulnay Sous Bois | France | ||
185 | Research Site | Avignon | France | ||
186 | Research Site | Bastia | France | ||
187 | Research Site | Bayonne | France | ||
188 | Research Site | Belfort | France | ||
189 | Research Site | Bernay | France | ||
190 | Research Site | Besancon | France | ||
191 | Research Site | Bethune | France | ||
192 | Research Site | Beziers | France | ||
193 | Research Site | Biganos | France | ||
194 | Research Site | Bois Guillaume | France | ||
195 | Research Site | Bordeaux | France | ||
196 | Research Site | Bouoin Jallieu | France | ||
197 | Research Site | Bourges | France | ||
198 | Research Site | Brest | France | ||
199 | Research Site | Briey Cedex | France | ||
200 | Research Site | Brive La Gaillarde | France | ||
201 | Research Site | Cachan | France | ||
202 | Research Site | Caen Cedex 4 | France | ||
203 | Research Site | Cagnes Sur Mer | France | ||
204 | Research Site | Caluire Et Cuire | France | ||
205 | Research Site | Cambrai | France | ||
206 | Research Site | Carpentras | France | ||
207 | Research Site | Castelnau Le Lez | France | ||
208 | Research Site | Castres | France | ||
209 | Research Site | Cavaillon | France | ||
210 | Research Site | Challans | France | ||
211 | Research Site | Chalons En Champagne | France | ||
212 | Research Site | Charleville Mezieres | France | ||
213 | Research Site | Chateauroux | France | ||
214 | Research Site | Chauny | France | ||
215 | Research Site | Chaville | France | ||
216 | Research Site | Chevillu Larue Cedex | France | ||
217 | Research Site | Cholet | France | ||
218 | Research Site | Cluses | France | ||
219 | Research Site | Colmar | France | ||
220 | Research Site | Colma | France | ||
221 | Research Site | Colomiers | France | ||
222 | Research Site | Corbeil Essonnes | France | ||
223 | Research Site | Creteil Cedex | France | ||
224 | Research Site | Denain Cedex | France | ||
225 | Research Site | Eaubonne | France | ||
226 | Research Site | Echirolles | France | ||
227 | Research Site | Ecully | France | ||
228 | Research Site | Epernay | France | ||
229 | Research Site | Epinal | France | ||
230 | Research Site | Etampes | France | ||
231 | Research Site | Ferolles Attilly | France | ||
232 | Research Site | Forbach | France | ||
233 | Research Site | Gentilly | France | ||
234 | Research Site | Gleize | France | ||
235 | Research Site | Grasse | France | ||
236 | Research Site | Grenoble | France | ||
237 | Research Site | Hagondange | France | ||
238 | Research Site | Hazebrouck | France | ||
239 | Research Site | Herblay | France | ||
240 | Research Site | Hyeres | France | ||
241 | Research Site | Joue Les Tours | France | ||
242 | Research Site | Juan Les Pins | France | ||
243 | Research Site | La Garda | France | ||
244 | Research Site | La Roche Sur Yon | France | ||
245 | Research Site | La Rochelle | France | ||
246 | Research Site | La Teste De Buch | France | ||
247 | Research Site | Lagny Sur Marne | France | ||
248 | Research Site | Langon | France | ||
249 | Research Site | Laval | France | ||
250 | Research Site | Le Bouscat | France | ||
251 | Research Site | Le Perreux Sur Marne | France | ||
252 | Research Site | Lens | France | ||
253 | Research Site | Les Sbles D Olonne | France | ||
254 | Research Site | Libourne | France | ||
255 | Research Site | Lille | France | ||
256 | Research Site | Limoges Cedex 1 | France | ||
257 | Research Site | Limoges | France | ||
258 | Research Site | Lorient | France | ||
259 | Research Site | Lunel | France | ||
260 | Research Site | Luneville | France | ||
261 | Research Site | Lyon | France | ||
262 | Research Site | Maisons Laffitte | France | ||
263 | Research Site | Mandelieu La Napoule | France | ||
264 | Research Site | Marmande | France | ||
265 | Research Site | Marseille | France | ||
266 | Research Site | Marselle | France | ||
267 | Research Site | Martigues | France | ||
268 | Research Site | Maubeuge | France | ||
269 | Research Site | Meaux | France | ||
270 | Research Site | Melun | France | ||
271 | Research Site | Mende | France | ||
272 | Research Site | Menton | France | ||
273 | Research Site | Metz | France | ||
274 | Research Site | Montauban | France | ||
275 | Research Site | Montbeliard | France | ||
276 | Research Site | Montereau Fault Yonne | France | ||
277 | Research Site | Montferrier Sur Lez | France | ||
278 | Research Site | Montigny Les Metz | France | ||
279 | Research Site | Montpellier | France | ||
280 | Research Site | Montreuil | France | ||
281 | Research Site | Nantes | France | ||
282 | Research Site | Narbonne | France | ||
283 | Research Site | Nevers Cedex | France | ||
284 | Research Site | Nice | France | ||
285 | Research Site | Nimes | France | ||
286 | Research Site | Niort | France | ||
287 | Research Site | Obernai | France | ||
288 | Research Site | Ollioules | France | ||
289 | Research Site | Oloron Ste Marie | France | ||
290 | Research Site | Orange | France | ||
291 | Research Site | Orleans | France | ||
292 | Research Site | Oyonnax | France | ||
293 | Research Site | Paris | France | ||
294 | Research Site | Pau Cedex | France | ||
295 | Research Site | Perigueux | France | ||
296 | Research Site | Perpignan | France | ||
297 | Research Site | Pertuis | France | ||
298 | Research Site | Pezenas | France | ||
299 | Research Site | Poitiers | France | ||
300 | Research Site | Pontault Combault | France | ||
301 | Research Site | Pontoise | France | ||
302 | Research Site | Privas | France | ||
303 | Research Site | Quimper | France | ||
304 | Research Site | Reims | France | ||
305 | Research Site | Rennes | France | ||
306 | Research Site | Reze | France | ||
307 | Research Site | Roanne | France | ||
308 | Research Site | Rochefort | France | ||
309 | Research Site | Romans Sur Isere | France | ||
310 | Research Site | Romorantin Lanthenay | France | ||
311 | Research Site | Rosny Sous Bois | France | ||
312 | Research Site | Rouen | France | ||
313 | Research Site | Rueil Malmaison | France | ||
314 | Research Site | Saint Etienne | France | ||
315 | Research Site | Saintes | France | ||
316 | Research Site | Salon De Provence | France | ||
317 | Research Site | Sarlat La Ceneda | France | ||
318 | Research Site | Schiltigheim | France | ||
319 | Research Site | Sedan | France | ||
320 | Research Site | Selestat | France | ||
321 | Research Site | Six Fours Les Plages | France | ||
322 | Research Site | St Amand Les Eaux | France | ||
323 | Research Site | St Andre Les Verges | France | ||
324 | Research Site | St Brieuc cedex 1 | France | ||
325 | Research Site | St Denis | France | ||
326 | Research Site | St Dizier | France | ||
327 | Research Site | St Esteve Cedex | France | ||
328 | Research Site | St Etienne | France | ||
329 | Research Site | St Girons | France | ||
330 | Research Site | St Herblain | France | ||
331 | Research Site | St Jean De Luz | France | ||
332 | Research Site | St Jean De Maurienne | France | ||
333 | Research Site | St Jean | France | ||
334 | Research Site | St Laurent Du Var Cedex | France | ||
335 | Research Site | St Malo | France | ||
336 | Research Site | St Orenes De Gameville | France | ||
337 | Research Site | St Quentin | France | ||
338 | Research Site | St Raphael | France | ||
339 | Research Site | Ste Feyre | France | ||
340 | Research Site | Strasbourg | France | ||
341 | Research Site | Tergnier | France | ||
342 | Research Site | Thionville | France | ||
343 | Research Site | Thonon Les Bains | France | ||
344 | Research Site | Toulon | France | ||
345 | Research Site | Toulouse | France | ||
346 | Research Site | Tours | France | ||
347 | Research Site | Valence | France | ||
348 | Research Site | Vannes | France | ||
349 | Research Site | Verneuil Sur Seine | France | ||
350 | Research Site | Vienne | France | ||
351 | Research Site | Villebon Sur Yvette | France | ||
352 | Research Site | Villejuif | France | ||
353 | Research Site | Viooefranche Sur Saone | France | ||
354 | Research Site | Voiron | France | ||
355 | Research Site | Aachen | Germany | ||
356 | Research Site | Annaberg-Buchholz | Germany | ||
357 | Research Site | Ansbach | Germany | ||
358 | Research Site | Apolda | Germany | ||
359 | Research Site | Aschaffenburg | Germany | ||
360 | Research Site | Auerbach | Germany | ||
361 | Research Site | Augusburg | Germany | ||
362 | Research Site | Bad Bramstedt | Germany | ||
363 | Research Site | Bad Lippspringe | Germany | ||
364 | Research Site | Bad Naustadt | Germany | ||
365 | Research Site | Bad Sassendorf | Germany | ||
366 | Research Site | Bergkamen | Germany | ||
367 | Research Site | Bergrheinfeld | Germany | ||
368 | Research Site | Berlin | Germany | ||
369 | Research Site | Bernau | Germany | ||
370 | Research Site | Bernsheim | Germany | ||
371 | Research Site | Beucha | Germany | ||
372 | Research Site | Bochum | Germany | ||
373 | Research Site | Bockenem | Germany | ||
374 | Research Site | Bogen | Germany | ||
375 | Research Site | Bonn | Germany | ||
376 | Research Site | Borna | Germany | ||
377 | Research Site | Braunschweig | Germany | ||
378 | Research Site | Buchholz | Germany | ||
379 | Research Site | Burgwedel | Germany | ||
380 | Research Site | Chemnitz | Germany | ||
381 | Research Site | Coswig | Germany | ||
382 | Research Site | Cottbus | Germany | ||
383 | Research Site | Deggendorf | Germany | ||
384 | Research Site | Dillingen | Germany | ||
385 | Research Site | Dortmund | Germany | ||
386 | Research Site | Dresden | Germany | ||
387 | Research Site | Dusseldorf | Germany | ||
388 | Research Site | Emeden | Germany | ||
389 | Research Site | Eppelborn | Germany | ||
390 | Research Site | Erfurt | Germany | ||
391 | Research Site | Essen | Germany | ||
392 | Research Site | Esslingen | Germany | ||
393 | Research Site | Flensburg | Germany | ||
394 | Research Site | Frankfurt | Germany | ||
395 | Research Site | Freiberg | Germany | ||
396 | Research Site | Freital | Germany | ||
397 | Research Site | Furstenfeldbruck | Germany | ||
398 | Research Site | Furstenwalde | Germany | ||
399 | Research Site | Furth | Germany | ||
400 | Research Site | Geesthacht | Germany | ||
401 | Research Site | Geisen | Germany | ||
402 | Research Site | Gelnhausen | Germany | ||
403 | Research Site | Gelsenkirchen | Germany | ||
404 | Research Site | Greven | Germany | ||
405 | Research Site | Gutersloh | Germany | ||
406 | Research Site | Hagen | Germany | ||
407 | Research Site | Halle | Germany | ||
408 | Research Site | Hamburg | Germany | ||
409 | Research Site | Hannover | Germany | ||
410 | Research Site | Heidelberg | Germany | ||
411 | Research Site | Heilbronn | Germany | ||
412 | Research Site | Hsloch | Germany | ||
413 | Research Site | Ingolstadt | Germany | ||
414 | Research Site | Kaarst | Germany | ||
415 | Research Site | Karlsruhe-Durlach | Germany | ||
416 | Research Site | Karlsruhe | Germany | ||
417 | Research Site | Kassel | Germany | ||
418 | Research Site | Katzhutte | Germany | ||
419 | Research Site | Kempten | Germany | ||
420 | Research Site | Ketzin | Germany | ||
421 | Research Site | Kiel | Germany | ||
422 | Research Site | Kippenheim | Germany | ||
423 | Research Site | Kirchhain | Germany | ||
424 | Research Site | Koln | Germany | ||
425 | Research Site | Krefeld | Germany | ||
426 | Research Site | Laage | Germany | ||
427 | Research Site | Landsberg | Germany | ||
428 | Research Site | Lebach | Germany | ||
429 | Research Site | Leipzig | Germany | ||
430 | Research Site | Lippstadt | Germany | ||
431 | Research Site | Lubeck | Germany | ||
432 | Research Site | Ludenscheid | Germany | ||
433 | Research Site | Lutjenburg | Germany | ||
434 | Research Site | Magdenburg | Germany | ||
435 | Research Site | Mainz | Germany | ||
436 | Research Site | Marburg | Germany | ||
437 | Research Site | Marl | Germany | ||
438 | Research Site | Meisen | Germany | ||
439 | Research Site | Mittelbach | Germany | ||
440 | Research Site | Moers | Germany | ||
441 | Research Site | Muhlhausen | Germany | ||
442 | Research Site | Mulheim | Germany | ||
443 | Research Site | Mulsen | Germany | ||
444 | Research Site | Munchen | Germany | ||
445 | Research Site | Neukirchen-Vluyn | Germany | ||
446 | Research Site | Neunkirchen | Germany | ||
447 | Research Site | Neunstadt | Germany | ||
448 | Research Site | Neuss | Germany | ||
449 | Research Site | Niesky | Germany | ||
450 | Research Site | Oranienburg | Germany | ||
451 | Research Site | Oschersleben | Germany | ||
452 | Research Site | Osnabr�ck | Germany | ||
453 | Research Site | Pirmasens | Germany | ||
454 | Research Site | Potsdam | Germany | ||
455 | Research Site | Potsda | Germany | ||
456 | Research Site | Rathenow | Germany | ||
457 | Research Site | Ratingen | Germany | ||
458 | Research Site | Recklinghausen | Germany | ||
459 | Research Site | Remscheid | Germany | ||
460 | Research Site | Rodgau | Germany | ||
461 | Research Site | Saarbrucken | Germany | ||
462 | Research Site | Saarlouis | Germany | ||
463 | Research Site | Sangerhausen | Germany | ||
464 | Research Site | Schimiedeberg | Germany | ||
465 | Research Site | Schwetzingen | Germany | ||
466 | Research Site | Silbitz | Germany | ||
467 | Research Site | Sindelfingen | Germany | ||
468 | Research Site | Solingen | Germany | ||
469 | Research Site | Stade | Germany | ||
470 | Research Site | Steinhagen | Germany | ||
471 | Research Site | Stockach | Germany | ||
472 | Research Site | Straelen | Germany | ||
473 | Research Site | Stutensee | Germany | ||
474 | Research Site | Stuttgart | Germany | ||
475 | Research Site | Tiefenbach | Germany | ||
476 | Research Site | Ueckermunde | Germany | ||
477 | Research Site | Wallerfangen | Germany | ||
478 | Research Site | Wedel | Germany | ||
479 | Research Site | Weimar | Germany | ||
480 | Research Site | Wesseling | Germany | ||
481 | Research Site | Weyhe | Germany | ||
482 | Research Site | Wilhelmshaven | Germany | ||
483 | Research Site | Wunstorf | Germany | ||
484 | Research Site | Wuppertal | Germany | ||
485 | Research Site | Alexandroupolos | Greece | ||
486 | Research Site | Athens | Greece | ||
487 | Research Site | Crete | Greece | ||
488 | Research Site | Kavala | Greece | ||
489 | Research Site | Larissa | Greece | ||
490 | Research Site | Thessaloniki | Greece | ||
491 | Research Site | Reykjavik | Iceland | ||
492 | Research Site | Bautry | Ireland | ||
493 | Research Site | Beaumont Park | Ireland | ||
494 | Research Site | Bishopstown | Ireland | ||
495 | Research Site | Blaemy | Ireland | ||
496 | Research Site | Blanchardstown | Ireland | ||
497 | Research Site | Canigtwohill | Ireland | ||
498 | Research Site | Carlow Town | Ireland | ||
499 | Research Site | Carrigaline | Ireland | ||
500 | Research Site | Clonakilty | Ireland | ||
501 | Research Site | Douglas East | Ireland | ||
502 | Research Site | Drogheda | Ireland | ||
503 | Research Site | Dublin | Ireland | ||
504 | Research Site | Gorey | Ireland | ||
505 | Research Site | Headford | Ireland | ||
506 | Research Site | Kilfinanen | Ireland | ||
507 | Research Site | Kilmallock | Ireland | ||
508 | Research Site | Kinvara | Ireland | ||
509 | Research Site | Macroom | Ireland | ||
510 | Research Site | Mallow | Ireland | ||
511 | Research Site | Maynooth | Ireland | ||
512 | Research Site | Mullingar | Ireland | ||
513 | Research Site | Naas | Ireland | ||
514 | Research Site | Phibsboro | Ireland | ||
515 | Research Site | Wexfoord | Ireland | ||
516 | Research Site | Acquaviva della Fonti | Italy | ||
517 | Research Site | Alba | Italy | ||
518 | Research Site | Alessandria | Italy | ||
519 | Research Site | Arezzo | Italy | ||
520 | Research Site | Ascoli Piceno | Italy | ||
521 | Research Site | Avellino | Italy | ||
522 | Research Site | Bari | Italy | ||
523 | Research Site | Benevento | Italy | ||
524 | Research Site | Bergamo | Italy | ||
525 | Research Site | Bologna | Italy | ||
526 | Research Site | Brescia | Italy | ||
527 | Research Site | Busto Arsizio | Italy | ||
528 | Research Site | Cagliari | Italy | ||
529 | Research Site | Cantanzaro | Italy | ||
530 | Research Site | Caserta | Italy | ||
531 | Research Site | Catania | Italy | ||
532 | Research Site | Catanzaro | Italy | ||
533 | Research Site | Cattinara | Italy | ||
534 | Research Site | Cava dei Tirreni | Italy | ||
535 | Research Site | Chieti | Italy | ||
536 | Research Site | Cittadella | Italy | ||
537 | Research Site | Como | Italy | ||
538 | Research Site | Coppito | Italy | ||
539 | Research Site | Crema | Italy | ||
540 | Research Site | Cuneo | Italy | ||
541 | Research Site | Fano | Italy | ||
542 | Research Site | Ferrara | Italy | ||
543 | Research Site | Firenze | Italy | ||
544 | Research Site | Foggia | Italy | ||
545 | Research Site | Genova | Italy | ||
546 | Research Site | Jesi | Italy | ||
547 | Research Site | Latina | Italy | ||
548 | Research Site | Lecco | Italy | ||
549 | Research Site | Livorno | Italy | ||
550 | Research Site | Lugo | Italy | ||
551 | Research Site | Lungro | Italy | ||
552 | Research Site | Macerata | Italy | ||
553 | Research Site | Matera | Italy | ||
554 | Research Site | Mercatino San Severiono | Italy | ||
555 | Research Site | Messina | Italy | ||
556 | Research Site | Milano | Italy | ||
557 | Research Site | Modena | Italy | ||
558 | Research Site | Monza | Italy | ||
559 | Research Site | Napoli | Italy | ||
560 | Research Site | Novara | Italy | ||
561 | Research Site | Orbassano | Italy | ||
562 | Research Site | Padova | Italy | ||
563 | Research Site | Palermo | Italy | ||
564 | Research Site | Parma | Italy | ||
565 | Research Site | Pavia | Italy | ||
566 | Research Site | Perugia | Italy | ||
567 | Research Site | Pesaro | Italy | ||
568 | Research Site | Pescara | Italy | ||
569 | Research Site | Pietra Ligure | Italy | ||
570 | Research Site | Pisa | Italy | ||
571 | Research Site | Pordenone | Italy | ||
572 | Research Site | Prato | Italy | ||
573 | Research Site | Reggio Calabria | Italy | ||
574 | Research Site | Reggio Emilia | Italy | ||
575 | Research Site | Rocca Priora | Italy | ||
576 | Research Site | Roma | Italy | ||
577 | Research Site | Rovigo | Italy | ||
578 | Research Site | Rozzano | Italy | ||
579 | Research Site | San Pietro Vernotico | Italy | ||
580 | Research Site | Sarzana | Italy | ||
581 | Research Site | Sassari | Italy | ||
582 | Research Site | Sesto San Giovanni | Italy | ||
583 | Research Site | Siena | Italy | ||
584 | Research Site | Siracusa | Italy | ||
585 | Research Site | Terni | Italy | ||
586 | Research Site | Torino | Italy | ||
587 | Research Site | Torrette | Italy | ||
588 | Research Site | Trapani | Italy | ||
589 | Research Site | Verona | Italy | ||
590 | Research Site | Vicenza | Italy | ||
591 | Research Site | Vimercate | Italy | ||
592 | Research Site | Beek en | Netherlands | ||
593 | Research Site | Beerzerveld | Netherlands | ||
594 | Research Site | Bennebroek | Netherlands | ||
595 | Research Site | Den Bosch | Netherlands | ||
596 | Research Site | Den Haag | Netherlands | ||
597 | Research Site | Deurne | Netherlands | ||
598 | Research Site | Dordrecht | Netherlands | ||
599 | Research Site | Echt | Netherlands | ||
600 | Research Site | Ermelo | Netherlands | ||
601 | Research Site | Fen Haag | Netherlands | ||
602 | Research Site | Hoogvliet | Netherlands | ||
603 | Research Site | Hoogwoud | Netherlands | ||
604 | Research Site | Lieshout | Netherlands | ||
605 | Research Site | Losser | Netherlands | ||
606 | Research Site | Nijmegen | Netherlands | ||
607 | Research Site | Oude-Pekela | Netherlands | ||
608 | Research Site | Poortvliet | Netherlands | ||
609 | Research Site | Rijswijk | Netherlands | ||
610 | Research Site | Roelofarends | Netherlands | ||
611 | Research Site | Soerendonk | Netherlands | ||
612 | Research Site | Spijkenisse | Netherlands | ||
613 | Research Site | Voerendaal | Netherlands | ||
614 | Research Site | Weerselo | Netherlands | ||
615 | Research Site | Wildevank | Netherlands | ||
616 | Research Site | Woerden | Netherlands | ||
617 | Research Site | Zaandam | Netherlands | ||
618 | Research Site | Zutphen | Netherlands | ||
619 | Research Site | Bergen | Norway | ||
620 | Research Site | B�verbru | Norway | ||
621 | Research Site | Elverum | Norway | ||
622 | Research Site | Fevik | Norway | ||
623 | Research Site | Fredrikstad | Norway | ||
624 | Research Site | Larvik | Norway | ||
625 | Research Site | Lovenstad | Norway | ||
626 | Research Site | Oslo | Norway | ||
627 | Research Site | Radal | Norway | ||
628 | Research Site | Roa | Norway | ||
629 | Research Site | Ski | Norway | ||
630 | Research Site | Ulstet | Norway | ||
631 | Research Site | Kasan | Russian Federation | ||
632 | Research Site | Moscow | Russian Federation | ||
633 | Research Site | St-Petersburg | Russian Federation | ||
634 | Research Site | Yaroslavl | Russian Federation | ||
635 | Research Site | Alcala de Henares | Spain | ||
636 | Research Site | Alcorcon | Spain | ||
637 | Research Site | Alicante Orihuela | Spain | ||
638 | Research Site | Alicante. Elda | Spain | ||
639 | Research Site | Andujar | Spain | ||
640 | Research Site | Aviles | Spain | ||
641 | Research Site | Badajoz | Spain | ||
642 | Research Site | Bailbao | Spain | ||
643 | Research Site | Barakaldi/Vizcaya | Spain | ||
644 | Research Site | Barakaldo Bizkaia | Spain | ||
645 | Research Site | Barcelona | Spain | ||
646 | Research Site | Burgos | Spain | ||
647 | Research Site | Caceres | Spain | ||
648 | Research Site | Cadiz | Spain | ||
649 | Research Site | Castellon | Spain | ||
650 | Research Site | Coruna | Spain | ||
651 | Research Site | Elche Alicante | Spain | ||
652 | Research Site | Ferrol | Spain | ||
653 | Research Site | Fuenlabrada | Spain | ||
654 | Research Site | Gandia | Spain | ||
655 | Research Site | Getafe | Spain | ||
656 | Research Site | Gijon | Spain | ||
657 | Research Site | Girona | Spain | ||
658 | Research Site | Granada | Spain | ||
659 | Research Site | Huelva | Spain | ||
660 | Research Site | Huercal Overa | Spain | ||
661 | Research Site | Jaen | Spain | ||
662 | Research Site | Laredo | Spain | ||
663 | Research Site | Leganes | Spain | ||
664 | Research Site | Lugo | Spain | ||
665 | Research Site | Madrid | Spain | ||
666 | Research Site | Malaga | Spain | ||
667 | Research Site | Manacor | Spain | ||
668 | Research Site | Marbella | Spain | ||
669 | Research Site | Merida | Spain | ||
670 | Research Site | Mostoles Madrid | Spain | ||
671 | Research Site | Murcia | Spain | ||
672 | Research Site | Orense | Spain | ||
673 | Research Site | Oviedo | Spain | ||
674 | Research Site | Palencia | Spain | ||
675 | Research Site | Palma Mallorca | Spain | ||
676 | Research Site | Pamplona | Spain | ||
677 | Research Site | Ponferrada | Spain | ||
678 | Research Site | Pontevedra | Spain | ||
679 | Research Site | Requena | Spain | ||
680 | Research Site | Ronda | Spain | ||
681 | Research Site | Sagunto | Spain | ||
682 | Research Site | Salamanca | Spain | ||
683 | Research Site | San Zebastian | Spain | ||
684 | Research Site | Santa Cruz d e Tenerife | Spain | ||
685 | Research Site | Santander | Spain | ||
686 | Research Site | Segovia | Spain | ||
687 | Research Site | Sevilla | Spain | ||
688 | Research Site | Valencia | Spain | ||
689 | Research Site | Valladolid | Spain | ||
690 | Research Site | Viadecans | Spain | ||
691 | Research Site | Vigo | Spain | ||
692 | Research Site | Vitoria | Spain | ||
693 | Research Site | Vizcaya | Spain | ||
694 | Research Site | Zaragoza | Spain | ||
695 | Research Site | Zaroma | Spain | ||
696 | Research Site | Akersberga | Sweden | ||
697 | Research Site | Arvidsjaur | Sweden | ||
698 | Research Site | Bromma | Sweden | ||
699 | Research Site | Eskilstuna | Sweden | ||
700 | Research Site | Gavle | Sweden | ||
701 | Research Site | Goteborg | Sweden | ||
702 | Research Site | Grangesberg | Sweden | ||
703 | Research Site | Hesingborg | Sweden | ||
704 | Research Site | Jarfalla | Sweden | ||
705 | Research Site | Karskrona | Sweden | ||
706 | Research Site | Kil | Sweden | ||
707 | Research Site | Laholm | Sweden | ||
708 | Research Site | Limhamn | Sweden | ||
709 | Research Site | Linkoping | Sweden | ||
710 | Research Site | Ludvika | Sweden | ||
711 | Research Site | Lulea | Sweden | ||
712 | Research Site | Malmo | Sweden | ||
713 | Research Site | Nacka | Sweden | ||
714 | Research Site | Orebro | Sweden | ||
715 | Research Site | Pitea | Sweden | ||
716 | Research Site | Stockholm | Sweden | ||
717 | Research Site | Torsas | Sweden | ||
718 | Research Site | Tyreso | Sweden | ||
719 | Research Site | Uppsala | Sweden | ||
720 | Research Site | Vannas | Sweden | ||
721 | Research Site | Varnamo | Sweden | ||
722 | Research Site | Vastra Fr�lunda | Sweden | ||
723 | Research Site | Vaxjo | Sweden | ||
724 | Research Site | Vinslov | Sweden | ||
725 | Research Site | Airdrie | United Kingdom | ||
726 | Research Site | Aldershot | United Kingdom | ||
727 | Research Site | Aylesbury | United Kingdom | ||
728 | Research Site | Ayrchire | United Kingdom | ||
729 | Research Site | Barry | United Kingdom | ||
730 | Research Site | Basildon | United Kingdom | ||
731 | Research Site | Bath | United Kingdom | ||
732 | Research Site | Belfast | United Kingdom | ||
733 | Research Site | Bellshill | United Kingdom | ||
734 | Research Site | Bexhill on Sea | United Kingdom | ||
735 | Research Site | Blackburn | United Kingdom | ||
736 | Research Site | Blantyre | United Kingdom | ||
737 | Research Site | Bolton | United Kingdom | ||
738 | Research Site | Borehamwood | United Kingdom | ||
739 | Research Site | Box | United Kingdom | ||
740 | Research Site | Bracknell | United Kingdom | ||
741 | Research Site | Bradford On Avon | United Kingdom | ||
742 | Research Site | Burbage | United Kingdom | ||
743 | Research Site | Bury St Edmonds | United Kingdom | ||
744 | Research Site | Canterbury | United Kingdom | ||
745 | Research Site | Cardiff | United Kingdom | ||
746 | Research Site | Chesterfield | United Kingdom | ||
747 | Research Site | Chippenham | United Kingdom | ||
748 | Research Site | Coatbridge | United Kingdom | ||
749 | Research Site | Cookstown | United Kingdom | ||
750 | Research Site | Corsham | United Kingdom | ||
751 | Research Site | Coventry | United Kingdom | ||
752 | Research Site | Crawley | United Kingdom | ||
753 | Research Site | Crowthorne | United Kingdom | ||
754 | Research Site | Cumbernauld | United Kingdom | ||
755 | Research Site | Darlington | United Kingdom | ||
756 | Research Site | Doncaste | United Kingdom | ||
757 | Research Site | Dumbarton | United Kingdom | ||
758 | Research Site | Dumfries | United Kingdom | ||
759 | Research Site | East Kilbride | United Kingdom | ||
760 | Research Site | Ecclwsfield | United Kingdom | ||
761 | Research Site | Ely | United Kingdom | ||
762 | Research Site | Fowey | United Kingdom | ||
763 | Research Site | Frome | United Kingdom | ||
764 | Research Site | Glasgow | United Kingdom | ||
765 | Research Site | Greenock | United Kingdom | ||
766 | Research Site | Hamilton | United Kingdom | ||
767 | Research Site | Headcorn | United Kingdom | ||
768 | Research Site | High Valleyfield | United Kingdom | ||
769 | Research Site | Huntington | United Kingdom | ||
770 | Research Site | Kirkintilloch | United Kingdom | ||
771 | Research Site | Larne | United Kingdom | ||
772 | Research Site | Leicester | United Kingdom | ||
773 | Research Site | Limavady | United Kingdom | ||
774 | Research Site | Lockerbie | United Kingdom | ||
775 | Research Site | London | United Kingdom | ||
776 | Research Site | Maidenhead | United Kingdom | ||
777 | Research Site | Manhester | United Kingdom | ||
778 | Research Site | Motherwell | United Kingdom | ||
779 | Research Site | New Stevenson | United Kingdom | ||
780 | Research Site | Newcastle | United Kingdom | ||
781 | Research Site | Newtonstewart | United Kingdom | ||
782 | Research Site | Newtownabbey | United Kingdom | ||
783 | Research Site | Northampton | United Kingdom | ||
784 | Research Site | Norwich | United Kingdom | ||
785 | Research Site | Nottingham | United Kingdom | ||
786 | Research Site | Nr Penzance | United Kingdom | ||
787 | Research Site | Paignton | United Kingdom | ||
788 | Research Site | Paisley | United Kingdom | ||
789 | Research Site | Penzance | United Kingdom | ||
790 | Research Site | Peterborough | United Kingdom | ||
791 | Research Site | Plymouth | United Kingdom | ||
792 | Research Site | Port Glasgow | United Kingdom | ||
793 | Research Site | Praze-on-Beeble | United Kingdom | ||
794 | Research Site | Reading | United Kingdom | ||
795 | Research Site | Reddich | United Kingdom | ||
796 | Research Site | Renfrew | United Kingdom | ||
797 | Research Site | Saltash | United Kingdom | ||
798 | Research Site | Sandy | United Kingdom | ||
799 | Research Site | Sheffield | United Kingdom | ||
800 | Research Site | Shepshed | United Kingdom | ||
801 | Research Site | Slough | United Kingdom | ||
802 | Research Site | Spalding | United Kingdom | ||
803 | Research Site | Spennymoor | United Kingdom | ||
804 | Research Site | Strathaven | United Kingdom | ||
805 | Research Site | Strathblane | United Kingdom | ||
806 | Research Site | Sunbury on Thames | United Kingdom | ||
807 | Research Site | Swindon | United Kingdom | ||
808 | Research Site | Thornhill | United Kingdom | ||
809 | Research Site | Thornton Heath | United Kingdom | ||
810 | Research Site | Tichfield | United Kingdom | ||
811 | Research Site | Torpoint | United Kingdom | ||
812 | Research Site | Trowbridge | United Kingdom | ||
813 | Research Site | Walsall | United Kingdom | ||
814 | Research Site | Welingborough | United Kingdom | ||
815 | Research Site | Wells next the sea | United Kingdom | ||
816 | Research Site | Weston-Super-Mare | United Kingdom | ||
817 | Research Site | Whitstable | United Kingdom | ||
818 | Research Site | Wishaw | United Kingdom | ||
819 | Research Site | Yaxley | United Kingdom |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: Michel Aubier, Prof, FRANCE
- Study Chair: Juliette Ostinelli, MD, AstraZeneca, MC France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D5890L00022
- EUROSMART
- EudraCTNo. 2006-006512-30
Study Results
Participant Flow
Recruitment Details | This was a 6-month, randomised, open label, parallel-group, active controlled, multinational study, in participants with uncontrolled/partly controlled asthma, who were symptomatic despite daily use of inhaled glucocorticosteroid (IGCS) with or without Long-Acting β2 agonist (LABA). |
---|---|
Pre-assignment Detail |
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 |
---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. |
Period Title: Overall Study | ||
STARTED | 4008 | 4045 |
COMPLETED | 3699 | 3705 |
NOT COMPLETED | 309 | 340 |
Baseline Characteristics
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 | Total |
---|---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. | Total of all reporting groups |
Overall Participants | 4008 | 4045 | 8053 |
Age (Years) [Mean (Full Range) ] | |||
Mean (Full Range) [Years] |
47.8
|
47.9
|
47.8
|
Sex: Female, Male (Count of Participants) | |||
Female |
2483
62%
|
2512
62.1%
|
4995
62%
|
Male |
1525
38%
|
1533
37.9%
|
3058
38%
|
Treatment with Long-Acting β2 agonist (LABA) at baseline. (Number) [Number] | |||
Number of participants using LABA at baseline. |
3108
77.5%
|
3118
77.1%
|
6226
77.3%
|
Number of participants without LABA at baseline. |
900
22.5%
|
927
22.9%
|
1827
22.7%
|
Asthma control questionnaire (ACQ5) score at study entry (Units on a scale) [Mean (Standard Deviation) ] | |||
ACQ5 score at study entry |
1.85
(0.98)
|
1.86
(1.01)
|
1.85
(0.99)
|
Exacerbations past 12 months before study start. (Number of exacerbations per participant) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Number of exacerbations per participant] |
1.47
(2.42)
|
1.42
(2.42)
|
1.45
(2.42)
|
Inhaled glucocorticosteroids (IGCS) dose at study entry. (μg/day) [Mean (Standard Deviation) ] | |||
IGCS dose at study entry |
1046
(595)
|
1037
(575)
|
1042
(585)
|
Participants with a well controlled asthma week at study entry. (Percentage of participants) [Mean (Full Range) ] | |||
Mean (Full Range) [Percentage of participants] |
11.97
0.3%
|
11.77
0.3%
|
11.87
0.1%
|
Pulmonary function test at baseline. (Percent of predicted normal value of PEF) [Mean (Full Range) ] | |||
Percent Included |
90.8
|
90.1
|
90.4
|
Outcome Measures
Title | Number of Severe Asthma Exacerbations Per Participant. |
---|---|
Description | Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 |
---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. |
Measure Participants | 4008 | 4045 |
Mean (Full Range) [Severe exacerbations per participant] |
0.097
(0)
|
0.080
(0)
|
Title | Fraction of Participants With Severe Asthma Exacerbation |
---|---|
Description | The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. |
Time Frame | 6 months. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 |
---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. |
Measure Participants | 4008 | 4045 |
Mean (95% Confidence Interval) [Fraction of participants with event] |
0.09686
(0.08528)
0%
|
0.07955
(0.06927)
0%
|
Title | Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. |
---|---|
Description | A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant |
Time Frame | 6 months. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 |
---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. |
Measure Participants | 4008 | 4045 |
Mean (Full Range) [Number of events per participant] |
0.0120
(0)
|
0.0091
(0)
|
Title | Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation |
---|---|
Description | Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. |
Time Frame | 6 months. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 |
---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. |
Measure Participants | 4008 | 4045 |
Mean (Standard Deviation) [Days per participant] |
9.6
(8.1)
|
9.1
(5.5)
|
Title | Mean Daily Number of Inhalations of As-needed Medication. |
---|---|
Description | The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment. |
Time Frame | 4 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2*2 Reporting Group |
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 |
---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. |
Measure Participants | 3880 | 3881 |
Mean (Full Range) [Inhalations per day per participant] |
0.897
(0)
|
0.625
(0)
|
Title | Percent of Participants With a Well Controlled Asthma Week. |
---|---|
Description | The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use. |
Time Frame | 6 months. |
Outcome Measure Data
Analysis Population Description |
---|
Data for this measure recorded by 3714 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2*2 Reporting Group. |
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 |
---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. |
Measure Participants | 3714 | 3718 |
Mean (Full Range) [Percentage of participants] |
43.69
(0)
1.1%
|
54.26
(0)
1.3%
|
Title | Mean Overall Asthma Control Questionnaire (ACQ) Score |
---|---|
Description | The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze. |
Time Frame | 6 months. |
Outcome Measure Data
Analysis Population Description |
---|
Data for this measure recorded by 3709 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2*2 Reporting Group. |
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 |
---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. |
Measure Participants | 3709 | 3735 |
Mean (Full Range) [Scores in a scale] |
1.18
(0)
|
1.089
(0)
|
Title | The Mean Total Daily Dose of Steroids From Symbicort. |
---|---|
Description | The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose. |
Time Frame | 4 weeks |
Outcome Measure Data
Analysis Population Description |
---|
: Data for this measure recorded by 3874 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2*2 Reporting Group. |
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 |
---|---|---|
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. |
Measure Participants | 3874 | 3873 |
Mean (Standard Deviation) [μg budesonide per day] |
462.96
(179.10)
|
736.58
(152.70)
|
Title | Mean Cost Per Participant Per Country |
---|---|
Description | Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated. |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 | ||
Arm/Group Description | 1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed. | 2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed. | ||
All Cause Mortality |
||||
Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 77/4008 (1.9%) | 88/4045 (2.2%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 1/4008 (0%) | 1/4045 (0%) | ||
Cardiac disorders | ||||
Angina Pectoris | 1/4008 (0%) | 1/4045 (0%) | ||
Atrial Fibrillation | 2/4008 (0%) | 1/4045 (0%) | ||
Atrioventricular Block | 1/4008 (0%) | 0/4045 (0%) | ||
Coronary Artery Disease | 1/4008 (0%) | 0/4045 (0%) | ||
Myocardial Infarction | 1/4008 (0%) | 1/4045 (0%) | ||
Tachyarrhythmia | 1/4008 (0%) | 0/4045 (0%) | ||
Tachycardia | 0/4008 (0%) | 1/4045 (0%) | ||
Congenital, familial and genetic disorders | ||||
Exomphalos | 1/4008 (0%) | 0/4045 (0%) | ||
Ear and labyrinth disorders | ||||
Vertigo | 1/4008 (0%) | 0/4045 (0%) | ||
Eye disorders | ||||
Cataract | 0/4008 (0%) | 2/4045 (0%) | ||
Gastrointestinal disorders | ||||
Abdominal Pain | 1/4008 (0%) | 0/4045 (0%) | ||
Abdominal Pain Lower | 1/4008 (0%) | 0/4045 (0%) | ||
Colitis | 2/4008 (0%) | 0/4045 (0%) | ||
Constipation | 1/4008 (0%) | 0/4045 (0%) | ||
Crohn's Disease | 1/4008 (0%) | 0/4045 (0%) | ||
Diarrhoea | 2/4008 (0%) | 0/4045 (0%) | ||
Diverticulum Intestinal | 0/4008 (0%) | 1/4045 (0%) | ||
Gastrointestinal Disorder | 1/4008 (0%) | 0/4045 (0%) | ||
Inguinal Hernia | 1/4008 (0%) | 1/4045 (0%) | ||
Pancreatitis | 1/4008 (0%) | 0/4045 (0%) | ||
Pancreatitis Acute | 1/4008 (0%) | 0/4045 (0%) | ||
Peritonitis | 1/4008 (0%) | 0/4045 (0%) | ||
Reflux Oesophagitis | 1/4008 (0%) | 0/4045 (0%) | ||
Salivary Gland Enlargement | 0/4008 (0%) | 1/4045 (0%) | ||
Umbilical Hernia | 1/4008 (0%) | 1/4045 (0%) | ||
Vomiting | 1/4008 (0%) | 0/4045 (0%) | ||
General disorders | ||||
Chest Pain | 2/4008 (0%) | 1/4045 (0%) | ||
Cyst | 0/4008 (0%) | 1/4045 (0%) | ||
Death | 1/4008 (0%) | 1/4045 (0%) | ||
Non-Cardiac Chest Pain | 1/4008 (0%) | 0/4045 (0%) | ||
Pain | 1/4008 (0%) | 0/4045 (0%) | ||
Hepatobiliary disorders | ||||
Cholecystitis | 0/4008 (0%) | 1/4045 (0%) | ||
Cholecystitis Acute | 0/4008 (0%) | 1/4045 (0%) | ||
Cholelithiasis | 0/4008 (0%) | 4/4045 (0.1%) | ||
Immune system disorders | ||||
Food Allergy | 0/4008 (0%) | 1/4045 (0%) | ||
Hypersensitivity | 0/4008 (0%) | 1/4045 (0%) | ||
Sarcoidosis | 0/4008 (0%) | 1/4045 (0%) | ||
Infections and infestations | ||||
Appendicitis | 1/4008 (0%) | 1/4045 (0%) | ||
Bronchiectasis | 1/4008 (0%) | 0/4045 (0%) | ||
Bronchitis | 0/4008 (0%) | 2/4045 (0%) | ||
Campylobacter Gastroenteritis | 1/4008 (0%) | 0/4045 (0%) | ||
Chronic Sinusitis | 0/4008 (0%) | 1/4045 (0%) | ||
Epstein-Barr Virus Infection | 0/4008 (0%) | 1/4045 (0%) | ||
Erysipelas | 1/4008 (0%) | 1/4045 (0%) | ||
Gastroenteritis | 1/4008 (0%) | 1/4045 (0%) | ||
Influenza | 1/4008 (0%) | 0/4045 (0%) | ||
Lower Respiratory Tract Infection | 1/4008 (0%) | 1/4045 (0%) | ||
Lung Infection | 0/4008 (0%) | 1/4045 (0%) | ||
Meningitis Viral | 0/4008 (0%) | 1/4045 (0%) | ||
Pilonidal Cyst | 0/4008 (0%) | 1/4045 (0%) | ||
Pneumonia | 3/4008 (0.1%) | 3/4045 (0.1%) | ||
Respiratory Tract Infection | 1/4008 (0%) | 0/4045 (0%) | ||
Sinusitis | 0/4008 (0%) | 1/4045 (0%) | ||
Tonsillitis | 0/4008 (0%) | 1/4045 (0%) | ||
Tracheobronchitis | 1/4008 (0%) | 0/4045 (0%) | ||
Injury, poisoning and procedural complications | ||||
Animal Bite | 0/4008 (0%) | 1/4045 (0%) | ||
Ankle Fracture | 1/4008 (0%) | 0/4045 (0%) | ||
Fall | 1/4008 (0%) | 1/4045 (0%) | ||
Femur Fracture | 1/4008 (0%) | 0/4045 (0%) | ||
Fibula Fracture | 1/4008 (0%) | 0/4045 (0%) | ||
Joint Dislocation | 1/4008 (0%) | 1/4045 (0%) | ||
Joint Injury | 0/4008 (0%) | 1/4045 (0%) | ||
Ligament Rupture | 1/4008 (0%) | 0/4045 (0%) | ||
Lower Limb Fracture | 0/4008 (0%) | 2/4045 (0%) | ||
Meniscus Lesion | 1/4008 (0%) | 0/4045 (0%) | ||
Multiple Drug Overdose | 0/4008 (0%) | 1/4045 (0%) | ||
Overdose | 0/4008 (0%) | 1/4045 (0%) | ||
Rib Fracture | 0/4008 (0%) | 1/4045 (0%) | ||
Tibia Fracture | 1/4008 (0%) | 0/4045 (0%) | ||
Traumatic Fracture | 0/4008 (0%) | 1/4045 (0%) | ||
Upper Limb Fracture | 1/4008 (0%) | 1/4045 (0%) | ||
Metabolism and nutrition disorders | ||||
Dehydration | 0/4008 (0%) | 1/4045 (0%) | ||
Hypokalaemia | 0/4008 (0%) | 1/4045 (0%) | ||
Type 2 Diabetes Mellitus | 0/4008 (0%) | 1/4045 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 0/4008 (0%) | 2/4045 (0%) | ||
Fibromyalgia | 0/4008 (0%) | 1/4045 (0%) | ||
Intervertebral Disc Protrusion | 1/4008 (0%) | 2/4045 (0%) | ||
Muscle Mass | 1/4008 (0%) | 0/4045 (0%) | ||
Muscle Spasms | 0/4008 (0%) | 1/4045 (0%) | ||
Muscular Weakness | 1/4008 (0%) | 0/4045 (0%) | ||
Osteoarthritis | 3/4008 (0.1%) | 3/4045 (0.1%) | ||
Spinal Disorder | 0/4008 (0%) | 1/4045 (0%) | ||
Tendonitis | 1/4008 (0%) | 0/4045 (0%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Basal Cell Carcinoma | 0/4008 (0%) | 1/4045 (0%) | ||
Bladder Neoplasm | 1/4008 (0%) | 0/4045 (0%) | ||
Breast Cancer | 0/4008 (0%) | 4/4045 (0.1%) | ||
Metastases To Liver | 0/4008 (0%) | 1/4045 (0%) | ||
Parathyroid Tumour Benign | 0/4008 (0%) | 1/4045 (0%) | ||
Prostate Cancer | 0/4008 (0%) | 1/4045 (0%) | ||
Uterine Leiomyoma | 1/4008 (0%) | 1/4045 (0%) | ||
Vocal Cord Neoplasm | 0/4008 (0%) | 1/4045 (0%) | ||
Nervous system disorders | ||||
Carotid Sinus Syndrome | 1/4008 (0%) | 0/4045 (0%) | ||
Cerebrovascular Accident | 1/4008 (0%) | 2/4045 (0%) | ||
Haemorrhage Intracranial | 1/4008 (0%) | 0/4045 (0%) | ||
Haemorrhagic Stroke | 1/4008 (0%) | 0/4045 (0%) | ||
Ischaemic Cerebral Infarction | 1/4008 (0%) | 0/4045 (0%) | ||
Loss Of Consciousness | 1/4008 (0%) | 0/4045 (0%) | ||
Migraine | 1/4008 (0%) | 0/4045 (0%) | ||
Syncope | 0/4008 (0%) | 1/4045 (0%) | ||
Pregnancy, puerperium and perinatal conditions | ||||
Abortion Spontaneous | 1/4008 (0%) | 0/4045 (0%) | ||
Reproductive system and breast disorders | ||||
Endometriosis | 0/4008 (0%) | 1/4045 (0%) | ||
Menorrhagia | 1/4008 (0%) | 0/4045 (0%) | ||
Vaginal Haemorrhage | 1/4008 (0%) | 0/4045 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Asthma | 13/4008 (0.3%) | 9/4045 (0.2%) | ||
Asthmatic Crisis | 0/4008 (0%) | 1/4045 (0%) | ||
Chronic Obstructive Pulmonary Disease | 0/4008 (0%) | 1/4045 (0%) | ||
Cough | 0/4008 (0%) | 1/4045 (0%) | ||
Dyspnoea | 1/4008 (0%) | 2/4045 (0%) | ||
Epistaxis | 0/4008 (0%) | 1/4045 (0%) | ||
Pharyngeal Disorder | 0/4008 (0%) | 1/4045 (0%) | ||
Pneumothorax | 1/4008 (0%) | 0/4045 (0%) | ||
Pulmonary Embolism | 0/4008 (0%) | 2/4045 (0%) | ||
Sleep Apnoea Syndrome | 1/4008 (0%) | 1/4045 (0%) | ||
Vascular disorders | ||||
Deep Vein Thrombosis | 1/4008 (0%) | 0/4045 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Symbicort® SMART®) 1*2 | Symbicort® SMART®) 2*2 | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4008 (0%) | 0/4045 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
Name/Title | Gerard Lynch |
---|---|
Organization | AstraZeneca |
Phone | |
aztrial_results_posting@astrazeneca.com |
- D5890L00022
- EUROSMART
- EudraCTNo. 2006-006512-30