DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00252863

Collaborator

(none)

1,600

Enrollment

167

Locations

Duration (Months)

9.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Symbicort, used twice daily (b.i.d) and as needed (prn) Drug: Budesonide Turbuhaler 200 µg Drug: Fluticasone Discus 250 µg Drug: Formoterol Turbuhaler 4.5 µg Drug: Terbutaline Turbuhaler 0.5 mg Drug: Salbutamol pressurized metered dose inhaler (pMDI) 100 µg Drug: Salmeterol Discus 50 µg Drug: Budesonide/Formoterol Turbuhaler 160/4.5 µg Drug: Fluticasone/Salmeterol Discus 250/50 µg Drug: Fluticasone/Salmeterol Discus 500/50 µg Drug: Theophylline 200 mg Drug: Theophylline 300 mg Drug: Singulair 10 mg	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 µg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-Week, Randomised, Open-Label, Parallel-Group, Multicentre Study

Study Start Date :

Dec 1, 2004

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Time to first severe asthma exacerbation []

Secondary Outcome Measures

Number of severe asthma exacerbations []
Mean use of as-needed medication []
Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period []
Prescribed asthma medication during the treatment period []
Asthma Control Questionnaire (ACQ) []
Patient's satisfaction with the treatment question []
Health care contacts []
Asthma medication []
Time lost from paid and unpaid work []
Serious adverse events (SAEs) []
Discontinuations due to adverse events (AEs) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone.

Exclusion Criteria:

Any other significant lung disease other than asthma
Any disease that might put patients at risk if they participate in the study

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Stuttgart	Baden-Württemberg	Germany
2	Research Site	München	Bayern	Germany
3	Research Site	Cottbus	Brandenburg	Germany
4	Research Site	Frankfurt	Hessen	Germany
5	Research Site	Rostock	Mecklenburg-Vorpommern	Germany
6	Research Site	Hannover	Niedersachsen	Germany
7	Research Site	Düsseldorf	Nordrhein-Westfalen	Germany
8	Research Site	Münster	Nordrhein-Westfalen	Germany
9	Research Site	Mainz	Rheinland-Pfalz	Germany
10	Research Site	Saarbrücken	Saarland	Germany
11	Research Site	Halle	Sachsen-Anhalt	Germany
12	Research Site	Dresden	Sachsen	Germany
13	Research Site	Bad Segeberg	Schleswig-Holstein	Germany
14	Research Site	Jena-Maua	Thüringen	Germany
15	Research Site	Amberg		Germany
16	Research Site	Aschaffenburg		Germany
17	Research Site	Auerbach		Germany
18	Research Site	Augsburg		Germany
19	Research Site	Backnang		Germany
20	Research Site	Bad Arolsen		Germany
21	Research Site	Bad Doberan		Germany
22	Research Site	Bad Lippspringe		Germany
23	Research Site	Bad Neuenahr		Germany
24	Research Site	Bad Reichenhall		Germany
25	Research Site	Bad Sessendorf		Germany
26	Research Site	Bayreuth		Germany
27	Research Site	Bensheim		Germany
28	Research Site	Bergisch Gladbach		Germany
29	Research Site	Berlin		Germany
30	Research Site	Bitte Eintragen		Germany
31	Research Site	Bochum		Germany
32	Research Site	Bonn		Germany
33	Research Site	Borna		Germany
34	Research Site	Brake		Germany
35	Research Site	Burgwedel		Germany
36	Research Site	Burg		Germany
37	Research Site	Castrop-Rauxel		Germany
38	Research Site	Chemnitz		Germany
39	Research Site	Coswig		Germany
40	Research Site	Cottbus		Germany
41	Research Site	Damme		Germany
42	Research Site	Darmstadt		Germany
43	Research Site	Deggendorf		Germany
44	Research Site	Dillingen		Germany
45	Research Site	Dinslaken		Germany
46	Research Site	Dortmund		Germany
47	Research Site	Dresden		Germany
48	Research Site	Dülmen		Germany
49	Research Site	Düsseldorf		Germany
50	Research Site	Eisenach		Germany
51	Research Site	Eisenhüttenstadt		Germany
52	Research Site	Emden		Germany
53	Research Site	Erfurt		Germany
54	Research Site	Erkelenz		Germany
55	Research Site	Eschwege		Germany
56	Research Site	Flensburg		Germany
57	Research Site	Forchheim		Germany
58	Research Site	Frankenthal		Germany
59	Research Site	Frankfurt		Germany
60	Research Site	Freiberg		Germany
61	Research Site	Freiburg		Germany
62	Research Site	Freising		Germany
63	Research Site	Fulda		Germany
64	Research Site	Fürstenwalde		Germany
65	Research Site	Fürth		Germany
66	Research Site	Gelsenkirchen		Germany
67	Research Site	Gießen		Germany
68	Research Site	Gotha		Germany
69	Research Site	Göppingen		Germany
70	Research Site	Günzburg		Germany
71	Research Site	Gütersloh		Germany
72	Research Site	Hagen		Germany
73	Research Site	Halle		Germany
74	Research Site	Hamburg		Germany
75	Research Site	Hamm		Germany
76	Research Site	Hannover		Germany
77	Research Site	Harpstedt		Germany
78	Research Site	Hartha		Germany
79	Research Site	Heidelberg		Germany
80	Research Site	Heilbronn		Germany
81	Research Site	Homburg-Saar		Germany
82	Research Site	Hoyerswerda		Germany
83	Research Site	Iserloh		Germany
84	Research Site	Kamenz		Germany
85	Research Site	Kamen		Germany
86	Research Site	Kamp-Lintfort		Germany
87	Research Site	Karlsruhe		Germany
88	Research Site	Kassel		Germany
89	Research Site	Kaufbeuren		Germany
90	Research Site	Kempten		Germany
91	Research Site	Kiel		Germany
92	Research Site	Kitzingen		Germany
93	Research Site	Koblenz		Germany
94	Research Site	Krefeld		Germany
95	Research Site	Kronach		Germany
96	Research Site	Köln		Germany
97	Research Site	Landsberg		Germany
98	Research Site	Leipzig		Germany
99	Research Site	Leonberg		Germany
100	Research Site	Leverkusen		Germany
101	Research Site	Ludwigsburg		Germany
102	Research Site	Lörrach		Germany
103	Research Site	Lübeck		Germany
104	Research Site	Lüneburg		Germany
105	Research Site	Magdeburg		Germany
106	Research Site	Mainaschaff		Germany
107	Research Site	Mainz		Germany
108	Research Site	Marburg		Germany
109	Research Site	Markkleeberg		Germany
110	Research Site	Memmingen		Germany
111	Research Site	Moers		Germany
112	Research Site	Mönchengladbach		Germany
113	Research Site	Mühlhausen		Germany
114	Research Site	München		Germany
115	Research Site	Neubrandenburg		Germany
116	Research Site	Neuss		Germany
117	Research Site	Neuwied		Germany
118	Research Site	Niesky		Germany
119	Research Site	Nordhausen		Germany
120	Research Site	Oberhausen		Germany
121	Research Site	Oranienburg		Germany
122	Research Site	Oschersleben		Germany
123	Research Site	Paderborn		Germany
124	Research Site	Passau		Germany
125	Research Site	Peine		Germany
126	Research Site	Pforzheim		Germany
127	Research Site	Pinneberg		Germany
128	Research Site	Potsdam		Germany
129	Research Site	Ratingen		Germany
130	Research Site	Recklinghausen		Germany
131	Research Site	Regensburg		Germany
132	Research Site	Reutlingen		Germany
133	Research Site	Rheine		Germany
134	Research Site	Rodenbach		Germany
135	Research Site	Rostock		Germany
136	Research Site	Rottweil		Germany
137	Research Site	Rudolstadt		Germany
138	Research Site	Saalfeld		Germany
139	Research Site	Saarbrücken		Germany
140	Research Site	Saarlouis		Germany
141	Research Site	Salzgitter		Germany
142	Research Site	Sangerhausen		Germany
143	Research Site	Schleswig		Germany
144	Research Site	Schwabach		Germany
145	Research Site	Schwerin		Germany
146	Research Site	Schwäbisch Gmünd		Germany
147	Research Site	Siegen		Germany
148	Research Site	Simmern		Germany
149	Research Site	Sindelfingen		Germany
150	Research Site	Singen		Germany
151	Research Site	Solingen		Germany
152	Research Site	Stade		Germany
153	Research Site	Stadthagen		Germany
154	Research Site	Steinhagen		Germany
155	Research Site	Stuttgart		Germany
156	Research Site	Trier		Germany
157	Research Site	Ulm		Germany
158	Research Site	Uttenreuth		Germany
159	Research Site	Wardenburg		Germany
160	Research Site	Wedel		Germany
161	Research Site	Weinheim		Germany
162	Research Site	Weyhe		Germany
163	Research Site	Witten		Germany
164	Research Site	Worpswede		Germany
165	Research Site	Würzburg		Germany
166	Research Site	Zerbst		Germany
167	Research Site	Zwickau		Germany