INVIGORATE: Exacerbation Study
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00845728
Collaborator
(none)
3,439
424
2
40
8.1
0.2
Study Details
Study Description
Brief Summary
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
3439 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD
Study Start Date
:
Mar 1, 2009
Actual Primary Completion Date
:
Jul 1, 2012
Actual Study Completion Date
:
Jul 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Indacaterol Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI) |
Drug: Indacaterol 150 µg
Indacaterol 150 µg o.d. delivered via SDDPI
|
| Active Comparator: Tiotropium Tiotropium 18 µg o.d. delivered via the handihaler® |
Drug: Tiotropium
Tiotropium 18 µg o.d. delivered via handihaler®
|
Outcome Measures
Primary Outcome Measures
- Trough Forced Expiratory Volume in 1 Second (FEV1). [12 weeks]
The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.
Secondary Outcome Measures
- Rate of COPD Exacerbations [52 weeks]
COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
-
Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe
COPD and including:
-
Smoking history of at least 10 pack years, both current and ex-smokers are eligible
-
A documented history of at least 1 moderate or severe exacerbation in the previous 12 months
Exclusion Criteria:
-
Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
-
Patients who have had a respiratory tract infection within 6 weeks prior to screening
-
Patients with concomitant pulmonary disease
-
Patients with a history of asthma
-
Patients with diabetes Type I or uncontrolled diabetes Type II
-
Any patient with lung cancer or a history of lung cancer
-
Patients with a history of certain cardiovascular comorbid conditions
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Capital Federal | Buenos Aires | Argentina | C1424BSF |
| 2 | Novartis Investigative Site | Mar del Plata | Buenos Aires | Argentina | 7600 |
| 3 | Novartis Investigative Site | Pilar | Buenos Aires | Argentina | B1629AHJ |
| 4 | Novartis Investigative Site | Rosario | Santa Fe | Argentina | C2000DSR |
| 5 | Novartis Investigative Site | Rosario | Santa Fe | Argentina | S2000AYW |
| 6 | Novartis Investigative Site | San Miguel de Tucuman | Tucuman | Argentina | 4000 |
| 7 | Novartis Investigative Site | Buenos Aires | Argentina | 5000 | |
| 8 | Novartis Investigative Site | Buenos Aires | Argentina | B1842DID | |
| 9 | Novartis Investigative Site | Buenos Aires | Argentina | C1122AAK | |
| 10 | Novartis Investigative Site | Buenos Aires | Argentina | C1125ABE | |
| 11 | Novartis Investigative Site | Buenos aires | Argentina | C1221ADC | |
| 12 | Novartis Investigative Site | Buenos Aires | Argentina | C1426ABP | |
| 13 | Novartis Investigative Site | Buenos Aires | Argentina | ||
| 14 | Novartis Investigative Site | Mendoza | Argentina | M5500CCG | |
| 15 | Novartis Investigative Site | Bankstown | New South Wales | Australia | 2200 |
| 16 | Novartis Investigative Site | Adelaide | South Australia | Australia | 5000 |
| 17 | Novartis Investigative Site | Daw Park | South Australia | Australia | 5041 |
| 18 | Novartis Investigative Site | Heidelberg | Victoria | Australia | 3084 |
| 19 | Novartis Investigative Site | Parkville | Victoria | Australia | 3050 |
| 20 | Novartis Investigative Site | Nedlands | Western Australia | Australia | 6009 |
| 21 | Novartis Investigative Site | Tauranga, New Zealand | Australia | 3001 | |
| 22 | Novartis Investigative Site | Feldbach | Austria | 8330 | |
| 23 | Novartis Investigative Site | Grieskirchen | Austria | 4710 | |
| 24 | Novartis Investigative Site | Gänserndorf | Austria | 2230 | |
| 25 | Novartis Investigative Site | Hallein | Austria | 5400 | |
| 26 | Novartis Investigative Site | Linz | Austria | 4020 | |
| 27 | Novartis Investigative Site | Perg | Austria | 4320 | |
| 28 | Novartis Investigative Site | Zwettl | Austria | 3910 | |
| 29 | Novartis Investigative Site | Aalst | Belgium | 9300 | |
| 30 | Novartis Investigative Site | Antwerpen | Belgium | 2020 | |
| 31 | Novartis Investigative Site | Bruxelles | Belgium | 1000 | |
| 32 | Novartis Investigative Site | Bruxelles | Belgium | 1200 | |
| 33 | Novartis Investigative Site | Duffel | Belgium | 2570 | |
| 34 | Novartis Investigative Site | Eupen | Belgium | 4700 | |
| 35 | Novartis Investigative Site | Framerie | Belgium | 7080 | |
| 36 | Novartis Investigative Site | Geraardsbergen | Belgium | 9500 | |
| 37 | Novartis Investigative Site | Gilly | Belgium | 6060 | |
| 38 | Novartis Investigative Site | Godinne | Belgium | 5530 | |
| 39 | Novartis Investigative Site | Gozée | Belgium | 6534 | |
| 40 | Novartis Investigative Site | Herentals | Belgium | 2200 | |
| 41 | Novartis Investigative Site | Jambes | Belgium | 5100 | |
| 42 | Novartis Investigative Site | Jette | Belgium | 1090 | |
| 43 | Novartis Investigative Site | Kortrijk | Belgium | 8500 | |
| 44 | Novartis Investigative Site | Leuven | Belgium | 3000 | |
| 45 | Novartis Investigative Site | Liege | Belgium | 4000 | |
| 46 | Novartis Investigative Site | Liège | Belgium | 4000 | |
| 47 | Novartis Investigative Site | Malmedy | Belgium | 4960 | |
| 48 | Novartis Investigative Site | Menen | Belgium | 8930 | |
| 49 | Novartis Investigative Site | Montigny-le-tilleul | Belgium | 6110 | |
| 50 | Novartis Investigative Site | Namur | Belgium | 5000 | |
| 51 | Novartis Investigative Site | Oostende | Belgium | 8400 | |
| 52 | Novartis Investigative Site | Turnhout | Belgium | 2300 | |
| 53 | Novartis Investigative Site | Goiania | GO | Brazil | 74605-050 |
| 54 | Novartis Investigative Site | Juiz de Fora | MG | Brazil | 36036-110 |
| 55 | Novartis Investigative Site | Rio de Janeiro | RJ | Brazil | 22271-110 |
| 56 | Novartis Investigative Site | Caxias do Sul | RS | Brazil | 95070-560 |
| 57 | Novartis Investigative Site | Porto Alegre | RS | Brazil | 90020-090 |
| 58 | Novartis Investigative Site | Porto Alegre | RS | Brazil | 90610-000 |
| 59 | Novartis Investigative Site | Porto Alegre | RS | Brazil | 90880-480 |
| 60 | Novartis Investigative Site | São Paulo | SP | Brazil | 04023-062 |
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| 118 | Novartis Investigative Site | Helsingor | Denmark | DK-3000 | |
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| 120 | Novartis Investigative Site | Odense C | Denmark | DK-5000 | |
| 121 | Novartis Investigative Site | Århus | Denmark | DK-8000 | |
| 122 | Novartis Investigative Site | Rakvere | Estonia | 44310 | |
| 123 | Novartis Investigative Site | Tallinn | Estonia | 13619 | |
| 124 | Novartis Investigative Site | Tartu | Estonia | 51014 | |
| 125 | Novartis Investigative Site | Helsinki | Finland | 00029 | |
| 126 | Novartis Investigative Site | HUS | Finland | 00029 | |
| 127 | Novartis Investigative Site | Jyvaskyla | Finland | 40100 | |
| 128 | Novartis Investigative Site | Pori | Finland | FIN-28500 | |
| 129 | Novartis Investigative Site | Porvoo | Finland | FIN-06200 | |
| 130 | Novartis Investigative Site | Tampere | Finland | FIN-33521 | |
| 131 | Novartis Investigative Site | Turku | Finland | FIN-20100 | |
| 132 | Novartis Investigative Site | Beuvry | France | 62660 | |
| 133 | Novartis Investigative Site | Bourges | France | 18000 | |
| 134 | Novartis Investigative Site | Ferolles-Attily | France | 77150 | |
| 135 | Novartis Investigative Site | Lyon cedex 04 | France | 69317 | |
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| 146 | Novartis Investigative Site | Bad Woerishofen | Germany | 86825 | |
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| 156 | Novartis Investigative Site | Bonn | Germany | 53119 | |
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| 158 | Novartis Investigative Site | Borstel | Germany | 23845 | |
| 159 | Novartis Investigative Site | Dachau | Germany | 85221 | |
| 160 | Novartis Investigative Site | Euskirchen | Germany | 53879 | |
| 161 | Novartis Investigative Site | Frankfurt | Germany | 60596 | |
| 162 | Novartis Investigative Site | Fürstenwalde/Spree | Germany | 15517 | |
| 163 | Novartis Investigative Site | Güstrow | Germany | 18273 | |
| 164 | Novartis Investigative Site | Hamburg | Germany | 20354 | |
| 165 | Novartis Investigative Site | Hamburg | Germany | 20357 | |
| 166 | Novartis Investigative Site | Hamburg | Germany | 22299 | |
| 167 | Novartis Investigative Site | Hamburg | Germany | 22305 | |
| 168 | Novartis Investigative Site | Hoyerswerda | Germany | 02977 | |
| 169 | Novartis Investigative Site | Landsberg | Germany | 86899 | |
| 170 | Novartis Investigative Site | Leipzig | Germany | 04207 | |
| 171 | Novartis Investigative Site | Mainz | Germany | D-55101 | |
| 172 | Novartis Investigative Site | Marburg | Germany | 35037 | |
| 173 | Novartis Investigative Site | Muenchen | Germany | 80331 | |
| 174 | Novartis Investigative Site | Muenchen | Germany | 80539 | |
| 175 | Novartis Investigative Site | Muenchen | Germany | 81243 | |
| 176 | Novartis Investigative Site | Muenchen | Germany | 81677 | |
| 177 | Novartis Investigative Site | München | Germany | 80335 | |
| 178 | Novartis Investigative Site | Neu-Ulm | Germany | 89231 | |
| 179 | Novartis Investigative Site | Neumünster | Germany | 24534 | |
| 180 | Novartis Investigative Site | Neuss | Germany | 41462 | |
| 181 | Novartis Investigative Site | Oranienburg | Germany | 16515 | |
| 182 | Novartis Investigative Site | Radebeul | Germany | 01445 | |
| 183 | Novartis Investigative Site | Ratingen | Germany | 40878 | |
| 184 | Novartis Investigative Site | Rüdersdorf | Germany | 15562 | |
| 185 | Novartis Investigative Site | Teterow | Germany | 17166 | |
| 186 | Novartis Investigative Site | Ulm | Germany | 89081 | |
| 187 | Novartis Investigative Site | Wedel | Germany | 22880 | |
| 188 | Novartis Investigative Site | Witten | Germany | 58452 | |
| 189 | Novartis Investigative Site | Budapest | Hungary | 1125 | |
| 190 | Novartis Investigative Site | Cegled | Hungary | 2700 | |
| 191 | Novartis Investigative Site | Debrecen | Hungary | 4032 | |
| 192 | Novartis Investigative Site | Deszk | Hungary | 6772 | |
| 193 | Novartis Investigative Site | Mosonmagyarovar | Hungary | 9200 | |
| 194 | Novartis Investigative Site | Nyiregyhaza | Hungary | 4400 | |
| 195 | Novartis Investigative Site | Sopron | Hungary | 9400 | |
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| 200 | Novartis Investigative Site | Hyderabad | Andhra Pradesh | India | 500004 |
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| 202 | Novartis Investigative Site | New Delhi | Delhi | India | 110029 |
| 203 | Novartis Investigative Site | Ahmedabad | Gujrat-India | India | 380054 |
| 204 | Novartis Investigative Site | Ahmedabad | Gujrat | India | 380009 |
| 205 | Novartis Investigative Site | Bangalore | Karnataka | India | 560 002 |
| 206 | Novartis Investigative Site | Bangalore | Karnataka | India | 560002 |
| 207 | Novartis Investigative Site | Mangalore | Karnataka | India | 575001 |
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| 213 | Novartis Investigative Site | Coimbatore | Tamil Nadu | India | 641 002 |
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| 216 | Novartis Investigative Site | Nagpur - Maharastra | India | 400 012 | |
| 217 | Novartis Investigative Site | Panjim | India | 403002 | |
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| 219 | Novartis Investigative Site | Jerusalem | Israel | 91120 | |
| 220 | Novartis Investigative Site | Ramat Gan | Israel | 52621 | |
| 221 | Novartis Investigative Site | Rehovot | Israel | 76100 | |
| 222 | Novartis Investigative Site | Tel-Aviv | Israel | 64239 | |
| 223 | Novartis Investigative Site | Acquaviva delle Fonti | BA | Italy | 70021 |
| 224 | Novartis Investigative Site | Bari | BA | Italy | 70124 |
| 225 | Novartis Investigative Site | Bergamo | BG | Italy | 24128 |
| 226 | Novartis Investigative Site | Brescia | BS | Italy | 25127 |
| 227 | Novartis Investigative Site | Catanzaro | CZ | Italy | 88100 |
| 228 | Novartis Investigative Site | Cona | FE | Italy | 44100 |
| 229 | Novartis Investigative Site | Cassino | FR | Italy | 03043 |
| 230 | Novartis Investigative Site | Genova | GE | Italy | 16132 |
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| 239 | Novartis Investigative Site | Roma | RM | Italy | 00133 |
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| 244 | Novartis Investigative Site | Siena | SI | Italy | 53100 |
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| 246 | Novartis Investigative Site | Orbassano | TO | Italy | 10043 |
| 247 | Novartis Investigative Site | Trieste | TS | Italy | 34149 |
| 248 | Novartis Investigative Site | Cuasso al Monte | VA | Italy | 21050 |
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| 250 | Novartis Investigative Site | Napoli | Italy | 80131 | |
| 251 | Novartis Investigative Site | Pisa | Italy | 56124 | |
| 252 | Novartis Investigative Site | Riga | LV | Latvia | LV-1038 |
| 253 | Novartis Investigative Site | Riga | Latvia | 1002 | |
| 254 | Novartis Investigative Site | Kaunas | Lithuania | 44320 | |
| 255 | Novartis Investigative Site | Klaipeda | Lithuania | LT-92231 | |
| 256 | Novartis Investigative Site | Siauliai | Lithuania | LT-76231 | |
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| 267 | Novartis Investigative Site | Enschede | Netherlands | 7513 ER | |
| 268 | Novartis Investigative Site | Rotterdam | Netherlands | 3045 PM | |
| 269 | Novartis Investigative Site | Sneek | Netherlands | 8601 ZK | |
| 270 | Novartis Investigative Site | Zwolle | Netherlands | 8011 JW | |
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| 272 | Novartis Investigative Site | Jesus Maria | Lima | Peru | 11 |
| 273 | Novartis Investigative Site | La Victoria | Lima | Peru | 13 |
| 274 | Novartis Investigative Site | Miraflores | Lima | Peru | 18 |
| 275 | Novartis Investigative Site | San Borja | Lima | Peru | 41 |
| 276 | Novartis Investigative Site | San Isidro | Lima | Peru | 27 |
| 277 | Novartis Investigative Site | San Martin de Porres | Lima | Peru | 31 |
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| 296 | Novartis Investigative Site | Lisboa | Portugal | 1169-024 | |
| 297 | Novartis Investigative Site | Lisboa | Portugal | 1649-035 | |
| 298 | Novartis Investigative Site | Lisboa | Portugal | 1769-001 | |
| 299 | Novartis Investigative Site | Porto | Portugal | 4200-319 | |
| 300 | Novartis Investigative Site | Bucharest | District 3 | Romania | 030303 |
| 301 | Novartis Investigative Site | Brasov | Jud. Brasov | Romania | 500118 |
| 302 | Novartis Investigative Site | Constanta | Jud. Constanta | Romania | 900002 |
| 303 | Novartis Investigative Site | Iasi | Jud. Iasi | Romania | 700115 |
| 304 | Novartis Investigative Site | Bucharest | Romania | 060011 | |
| 305 | Novartis Investigative Site | Cluj-Napoca | Romania | 400371 | |
| 306 | Novartis Investigative Site | Kazan | Tatarstan Republic | Russian Federation | 420015 |
| 307 | Novartis Investigative Site | Chelyabinsk | Russian Federation | 454021 | |
| 308 | Novartis Investigative Site | Chelyabinsk | Russian Federation | 454047 | |
| 309 | Novartis Investigative Site | Ekaterinburg | Russian Federation | 620109 | |
| 310 | Novartis Investigative Site | Ekaterinburg | Russian Federation | 620219 | |
| 311 | Novartis Investigative Site | Kazan | Russian Federation | 420015 | |
| 312 | Novartis Investigative Site | Moscow | Russian Federation | 105077 | |
| 313 | Novartis Investigative Site | Moscow | Russian Federation | 105229 | |
| 314 | Novartis Investigative Site | Moscow | Russian Federation | 115280 | |
| 315 | Novartis Investigative Site | Moscow | Russian Federation | 115446 | |
| 316 | Novartis Investigative Site | Moscow | Russian Federation | 119992 | |
| 317 | Novartis Investigative Site | Moscow | Russian Federation | 121359 | |
| 318 | Novartis Investigative Site | Moscow | Russian Federation | 121609 | |
| 319 | Novartis Investigative Site | Samara | Russian Federation | 443079 | |
| 320 | Novartis Investigative Site | Sankt-Peterburg | Russian Federation | 197022 | |
| 321 | Novartis Investigative Site | St. Petersburg | Russian Federation | 194354 | |
| 322 | Novartis Investigative Site | St.-Petersburg | Russian Federation | 193231 | |
| 323 | Novartis Investigative Site | Bratislava | Slovak Republic | Slovakia | 821 06 |
| 324 | Novartis Investigative Site | Kosice | Slovak Republic | Slovakia | 041 90 |
| 325 | Novartis Investigative Site | Spisska Nova Ves | Slovak Republic | Slovakia | 052 01 |
| 326 | Novartis Investigative Site | Bratislava | Slovakia | 826 06 | |
| 327 | Novartis Investigative Site | Kosice | Slovakia | 040 01 | |
| 328 | Novartis Investigative Site | Lucenec | Slovakia | 984 39 | |
| 329 | Novartis Investigative Site | Nove Zamky | Slovakia | 940 01 | |
| 330 | Novartis Investigative Site | Poprad | Slovakia | 058 01 | |
| 331 | Novartis Investigative Site | Bloemfontein | South Africa | 9301 | |
| 332 | Novartis Investigative Site | Bloemfontein | South Africa | 9317 | |
| 333 | Novartis Investigative Site | Cape Town | South Africa | 8001 | |
| 334 | Novartis Investigative Site | Durban | South Africa | 4001 | |
| 335 | Novartis Investigative Site | Jerez de La Frontera | Andalucia | Spain | 11407 |
| 336 | Novartis Investigative Site | Malaga | Andalucia | Spain | 29010 |
| 337 | Novartis Investigative Site | Sanlúcar de Barrameda | Andalucia | Spain | 11540 |
| 338 | Novartis Investigative Site | Sevilla | Andalucia | Spain | 41009 |
| 339 | Novartis Investigative Site | Gijon | Asturias | Spain | 33290 |
| 340 | Novartis Investigative Site | Illescas | Castilla la Mancha | Spain | 45200 |
| 341 | Novartis Investigative Site | Valladolid | Castilla y Leon | Spain | 47011 |
| 342 | Novartis Investigative Site | Barcelona | Cataluña | Spain | 08003 |
| 343 | Novartis Investigative Site | Barcelona | Cataluña | Spain | 08036 |
| 344 | Novartis Investigative Site | Barcelona | Cataluña | Spain | 08041 |
| 345 | Novartis Investigative Site | Salt | Cataluña | Spain | 17190 |
| 346 | Novartis Investigative Site | Sant Boi de Llobregat | Cataluña | Spain | 08830 |
| 347 | Novartis Investigative Site | Terrassa | Cataluña | Spain | 08221 |
| 348 | Novartis Investigative Site | Vic | Cataluña | Spain | 08500 |
| 349 | Novartis Investigative Site | Alicante | Comunidad Valenciana | Spain | 03114 |
| 350 | Novartis Investigative Site | Alzira | Comunidad Valenciana | Spain | 46600 |
| 351 | Novartis Investigative Site | Requena | Comunidad Valenciana | Spain | 46340 |
| 352 | Novartis Investigative Site | Caceres | Extremadura | Spain | 10003 |
| 353 | Novartis Investigative Site | Mérida | Extremadura | Spain | 06800 |
| 354 | Novartis Investigative Site | Plasencia | Extremadura | Spain | 10600 |
| 355 | Novartis Investigative Site | La Coruna | Galicia | Spain | 15006 |
| 356 | Novartis Investigative Site | Lugo | Galicia | Spain | 27003 |
| 357 | Novartis Investigative Site | Santiago de Compostela | Galicia | Spain | 15706 |
| 358 | Novartis Investigative Site | Pozuelo de Alarcón | Madrid | Spain | 28223 |
| 359 | Novartis Investigative Site | Madrid | Spain | 28007 | |
| 360 | Novartis Investigative Site | Madrid | Spain | 28040 | |
| 361 | Novartis Investigative Site | Göteborg | Sweden | 412 63 | |
| 362 | Novartis Investigative Site | Göteborg | Sweden | 413 45 | |
| 363 | Novartis Investigative Site | Luleå | Sweden | SE-971 80 | |
| 364 | Novartis Investigative Site | Lund | Sweden | SE-221 85 | |
| 365 | Novartis Investigative Site | Malmö | Sweden | 205 02 | |
| 366 | Novartis Investigative Site | Skellefteå | Sweden | SE 931 32 | |
| 367 | Novartis Investigative Site | Stockholm | Sweden | S-171 76 | |
| 368 | Novartis Investigative Site | Sundsvall | Sweden | 851 86 | |
| 369 | Novartis Investigative Site | Faltigberg-Wald | ZH | Switzerland | 8639 |
| 370 | Novartis Investigative Site | Bern | Switzerland | 3013 | |
| 371 | Novartis Investigative Site | Crans-Montana | Switzerland | 3963 | |
| 372 | Novartis Investigative Site | Lausanne | Switzerland | 1011 | |
| 373 | Novartis Investigative Site | St. Gallen | Switzerland | 9007 | |
| 374 | Novartis Investigative Site | Thun | Switzerland | 3600 | |
| 375 | Novartis Investigative Site | Winterthur | Switzerland | 8401 | |
| 376 | Novartis Investigative Site | Zuerich | Switzerland | 8032 | |
| 377 | Novartis Investigative Site | Taichung | Taiwan | 40447 | |
| 378 | Novartis Investigative Site | Taichung | Taiwan | 40705 | |
| 379 | Novartis Investigative Site | Taipei County | Taiwan | ||
| 380 | Novartis Investigative Site | Taipei | Taiwan | 10002 | |
| 381 | Novartis Investigative Site | Taipei | Taiwan | 110 | |
| 382 | Novartis Investigative Site | Bangkok | Thailand | 10700 | |
| 383 | Novartis Investigative Site | Chiang Mai | Thailand | 50200 | |
| 384 | Novartis Investigative Site | Khon Kaen | Thailand | 40002 | |
| 385 | Novartis Investigative Site | Songkla | Thailand | 90110 | |
| 386 | Novartis Investigative Site | Ankara | Turkey | 06100 | |
| 387 | Novartis Investigative Site | Canakkale | Turkey | 17100 | |
| 388 | Novartis Investigative Site | Diskapi / Ankara | Turkey | 06110 | |
| 389 | Novartis Investigative Site | Emek / Ankara | Turkey | 06510 | |
| 390 | Novartis Investigative Site | Gaziantep | Turkey | 27070 | |
| 391 | Novartis Investigative Site | Isparta | Turkey | 32100 | |
| 392 | Novartis Investigative Site | Istanbul | Turkey | ||
| 393 | Novartis Investigative Site | Izmir | Turkey | 35340 | |
| 394 | Novartis Investigative Site | Kahramanmaras | Turkey | 46100 | |
| 395 | Novartis Investigative Site | Kecioren / Ankara | Turkey | 06280 | |
| 396 | Novartis Investigative Site | Kozlu / Zonguldak | Turkey | 67600 | |
| 397 | Novartis Investigative Site | Malatya | Turkey | 44280 | |
| 398 | Novartis Investigative Site | Mersin | Turkey | 33079 | |
| 399 | Novartis Investigative Site | Yenisehir/Izmir | Turkey | 35110 | |
| 400 | Novartis Investigative Site | Swansea | England | United Kingdom | SA6 6NL |
| 401 | Novartis Investigative Site | Newcastle Upon Tyne | Newcastle | United Kingdom | NE7 7DN |
| 402 | Novartis Investigative Site | Ash Vale | Surrey | United Kingdom | GU12 5BA |
| 403 | Novartis Investigative Site | Crawley | West Sussex | United Kingdom | RH10 7DX |
| 404 | Novartis Investigative Site | Belfast | United Kingdom | BT7 2BE | |
| 405 | Novartis Investigative Site | Bexhill-on-Sea | United Kingdom | TN40 1JJ | |
| 406 | Novartis Investigative Site | Bradford | United Kingdom | BD9 6RJ | |
| 407 | Novartis Investigative Site | Bristol | United Kingdom | BS10 5NB | |
| 408 | Novartis Investigative Site | Cambridge | United Kingdom | CB7 5JD | |
| 409 | Novartis Investigative Site | Lancashire | United Kingdom | B13 6TL | |
| 410 | Novartis Investigative Site | Lancashire | United Kingdom | FY3 7EN | |
| 411 | Novartis Investigative Site | Liverpool | United Kingdom | L9 7AL | |
| 412 | Novartis Investigative Site | London | United Kingdom | E2 9JX | |
| 413 | Novartis Investigative Site | London | United Kingdom | SW3 6PH | |
| 414 | Novartis Investigative Site | London | United Kingdom | W1G 8HU | |
| 415 | Novartis Investigative Site | Newport | United Kingdom | P030 5TG | |
| 416 | Novartis Investigative Site | Stockport | United Kingdom | SK4 4NX | |
| 417 | Novartis Investigative Site | Stockport | United Kingdom | SK8 6LU | |
| 418 | Novartis Investigative Site | Surrey | United Kingdom | KT16 0PZ | |
| 419 | Novartis Investigative Site | Warminster | United Kingdom | BA12 9AA | |
| 420 | Novartis Investigative Site | Watford | United Kingdom | WD25 0EA | |
| 421 | Novartis Investigative Site | Windsor | United Kingdom | SL4 3DP | |
| 422 | Novartis Investigative Site | Valencia | Estado Carabobo | Venezuela | 2005 |
| 423 | Novartis Investigative Site | Barquisimeto | Estado Lara | Venezuela | 3002 |
| 424 | Novartis Investigative Site | Maracaibo | Estado Zulia | Venezuela | 4002 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00845728
Other Study ID Numbers:
- CQAB149B2348
- 2008-007944-33
First Posted:
Feb 18, 2009
Last Update Posted:
Nov 19, 2013
Last Verified:
Sep 1, 2013
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 3,444 patients were randomized, but only 3,439 received treatment as 5 patients were mis-randomized. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Indacaterol | Tiotropium |
|---|---|---|
| Arm/Group Description | Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) | Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI |
| Period Title: Overall Study | ||
| STARTED | 1723 | 1721 |
| Exposed | 1721 | 1718 |
| COMPLETED | 1337 | 1379 |
| NOT COMPLETED | 386 | 342 |
Baseline Characteristics
| Arm/Group Title | Indacaterol | Tiotropium | Total |
|---|---|---|---|
| Arm/Group Description | Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) | Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI | Total of all reporting groups |
| Overall Participants | 1721 | 1718 | 3439 |
| Age, Customized (Number) [Number] | |||
| <65 years |
929
54%
|
909
52.9%
|
1838
53.4%
|
| ≥ 65 years |
792
46%
|
809
47.1%
|
1601
46.6%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
377
21.9%
|
405
23.6%
|
782
22.7%
|
| Male |
1344
78.1%
|
1313
76.4%
|
2657
77.3%
|
Outcome Measures
| Title | Trough Forced Expiratory Volume in 1 Second (FEV1). |
|---|---|
| Description | The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-Protocol Set for Spirometry (PPS-S) This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy. |
| Arm/Group Title | Indacaterol | Tiotropium |
|---|---|---|
| Arm/Group Description | Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) | Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI |
| Measure Participants | 1450 | 1467 |
| Least Squares Mean (Standard Error) [Liters] |
1.134
(0.0008)
|
1.145
(0.0008)
|
| Title | Rate of COPD Exacerbations |
|---|---|
| Description | COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-Protocol Set for Exacerbations (PPS-E). This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy. |
| Arm/Group Title | Indacaterol | Tiotropium |
|---|---|---|
| Arm/Group Description | Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) | Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI |
| Measure Participants | 1675 | 1675 |
| Number [Exacerbations per patient per year] |
0.79
|
0.61
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | IndIndacaterol | Tiotropium | ||
| Arm/Group Description | Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) | Tiotropium 18 μg o.d. delivered via the manufacturer's proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI | ||
All Cause Mortality |
||||
| IndIndacaterol | Tiotropium | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| IndIndacaterol | Tiotropium | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 263/1721 (15.3%) | 255/1718 (14.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/1721 (0%) | 3/1718 (0.2%) | ||
| Iron deficiency anaemia | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Leukopenia | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Acute myocardial infarction | 3/1721 (0.2%) | 2/1718 (0.1%) | ||
| Angina pectoris | 5/1721 (0.3%) | 5/1718 (0.3%) | ||
| Angina unstable | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Aortic valve calcification | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Arrhythmia | 3/1721 (0.2%) | 1/1718 (0.1%) | ||
| Arrhythmia supraventricular | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Arteriosclerosis coronary artery | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Atrial fibrillation | 3/1721 (0.2%) | 4/1718 (0.2%) | ||
| Atrial flutter | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| Atrioventricular block | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Atrioventricular block first degree | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Bradycardia | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Bundle branch block left | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Cardiac arrest | 3/1721 (0.2%) | 2/1718 (0.1%) | ||
| Cardiac failure | 3/1721 (0.2%) | 5/1718 (0.3%) | ||
| Cardiac failure chronic | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Cardiac failure congestive | 3/1721 (0.2%) | 1/1718 (0.1%) | ||
| Cardio-respiratory arrest | 3/1721 (0.2%) | 2/1718 (0.1%) | ||
| Cardiomegaly | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Cardiomyopathy | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Cardiopulmonary failure | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Congestive cardiomyopathy | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Cor pulmonale | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Coronary artery disease | 1/1721 (0.1%) | 3/1718 (0.2%) | ||
| Cyanosis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Diastolic dysfunction | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Ischaemic cardiomyopathy | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Left ventricular hypertrophy | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Mitral valve incompetence | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Myocardial infarction | 4/1721 (0.2%) | 8/1718 (0.5%) | ||
| Myocardial ischaemia | 6/1721 (0.3%) | 4/1718 (0.2%) | ||
| Palpitations | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Right ventricular failure | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Sinus bradycardia | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Supraventricular extrasystoles | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Tachyarrhythmia | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Ear and labyrinth disorders | ||||
| Hypoacusis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Vertigo | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Endocrine disorders | ||||
| Goitre | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Eye disorders | ||||
| Angle closure glaucoma | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Cataract | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Maculopathy | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Retinal vein occlusion | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Gastrointestinal disorders | ||||
| Abdominal hernia | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Abdominal pain | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Abdominal pain upper | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Acute abdomen | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Ascites | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Colitis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Colitis ulcerative | 0/1721 (0%) | 3/1718 (0.2%) | ||
| Colonic polyp | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Constipation | 1/1721 (0.1%) | 3/1718 (0.2%) | ||
| Diarrhoea | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Diverticulum | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Duodenal fistula | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Duodenitis | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Enteritis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Gastric ulcer | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Gastritis | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Gastrooesophageal reflux disease | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Haematemesis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Ileus | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Inguinal hernia | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Intestinal ischaemia | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Intestinal obstruction | 3/1721 (0.2%) | 0/1718 (0%) | ||
| Mallory-Weiss syndrome | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Melaena | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Nausea | 2/1721 (0.1%) | 0/1718 (0%) | ||
| Oesophagitis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Pancreatitis | 0/1721 (0%) | 3/1718 (0.2%) | ||
| Pancreatitis acute | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Regurgitation | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Sigmoiditis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Small intestinal obstruction | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Thrombosis mesenteric vessel | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Umbilical hernia | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Upper gastrointestinal haemorrhage | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| General disorders | ||||
| Chills | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Death | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Device dislocation | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Drug ineffective | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Malaise | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Multi-organ failure | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Non-cardiac chest pain | 4/1721 (0.2%) | 1/1718 (0.1%) | ||
| Oedema due to cardiac disease | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Oedema peripheral | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| Pyrexia | 3/1721 (0.2%) | 1/1718 (0.1%) | ||
| Soft tissue inflammation | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Sudden cardiac death | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Sudden death | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Hepatobiliary disorders | ||||
| Bile duct stone | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Cholangitis acute | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Cholecystitis | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Cholelithiasis | 1/1721 (0.1%) | 2/1718 (0.1%) | ||
| Gallbladder fistula | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Hepatic function abnormal | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Hyperbilirubinaemia | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Jaundice | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Immune system disorders | ||||
| Drug hypersensitivity | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Infections and infestations | ||||
| Anal abscess | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Appendicitis perforated | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Bronchitis | 3/1721 (0.2%) | 2/1718 (0.1%) | ||
| Bronchitis bacterial | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Bronchopneumonia | 2/1721 (0.1%) | 3/1718 (0.2%) | ||
| Clostridial infection | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Diverticulitis | 1/1721 (0.1%) | 2/1718 (0.1%) | ||
| Gastroenteritis | 0/1721 (0%) | 2/1718 (0.1%) | ||
| H1N1 influenza | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Helicobacter infection | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Herpes zoster | 1/1721 (0.1%) | 4/1718 (0.2%) | ||
| Influenza | 4/1721 (0.2%) | 2/1718 (0.1%) | ||
| Intervertebral discitis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Lobar pneumonia | 4/1721 (0.2%) | 4/1718 (0.2%) | ||
| Lower respiratory tract infection | 28/1721 (1.6%) | 18/1718 (1%) | ||
| Lower respiratory tract infection bacterial | 4/1721 (0.2%) | 2/1718 (0.1%) | ||
| Lower respiratory tract infection viral | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Lung abscess | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Lung infection | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Meningitis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Meningitis viral | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Nasopharyngitis | 3/1721 (0.2%) | 3/1718 (0.2%) | ||
| Oral candidiasis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Pneumococcal sepsis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Pneumonia | 29/1721 (1.7%) | 24/1718 (1.4%) | ||
| Pneumonia bacterial | 1/1721 (0.1%) | 2/1718 (0.1%) | ||
| Pneumonia pneumococcal | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Pneumonia staphylococcal | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Pseudomonas infection | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Pulmonary tuberculosis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Respiratory tract infection bacterial | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Respiratory tract infection viral | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Sepsis | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Septic shock | 1/1721 (0.1%) | 3/1718 (0.2%) | ||
| Sinusitis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Testicular abscess | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Tracheobronchitis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Upper respiratory tract infection | 3/1721 (0.2%) | 2/1718 (0.1%) | ||
| Upper respiratory tract infection bacterial | 18/1721 (1%) | 16/1718 (0.9%) | ||
| Urinary tract infection | 1/1721 (0.1%) | 2/1718 (0.1%) | ||
| Urosepsis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Viral sepsis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Viral upper respiratory tract infection | 12/1721 (0.7%) | 11/1718 (0.6%) | ||
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Concussion | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Contusion | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Fall | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| Femoral neck fracture | 1/1721 (0.1%) | 2/1718 (0.1%) | ||
| Femur fracture | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Hip fracture | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Penetrating abdominal trauma | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Post procedural fistula | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Rib fracture | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| Tibia fracture | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Traumatic shock | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Investigations | ||||
| Arteriogram coronary | 0/1721 (0%) | 1/1718 (0.1%) | ||
| C-reactive protein increased | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Prostatic specific antigen increased | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Diabetes mellitus | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Diabetes mellitus inadequate control | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Hyperkalaemia | 2/1721 (0.1%) | 0/1718 (0%) | ||
| Hyponatraemia | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Axillary mass | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Back pain | 4/1721 (0.2%) | 0/1718 (0%) | ||
| Cervical spinal stenosis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Exostosis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Intervertebral disc degeneration | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Intervertebral disc disorder | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Intervertebral disc protrusion | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Musculoskeletal chest pain | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Musculoskeletal pain | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Myalgia | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Neck pain | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Osteonecrosis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Rotator cuff syndrome | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Spinal column stenosis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Spinal osteoarthritis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Benign neoplasm of prostate | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Bladder cancer | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Bladder papilloma | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Breast cancer | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Bronchial carcinoma | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Colon adenoma | 2/1721 (0.1%) | 0/1718 (0%) | ||
| Colon cancer | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| Colon neoplasm | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Gallbladder cancer | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Gastric cancer | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Glioblastoma | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Lung adenocarcinoma | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Lung cancer metastatic | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Lung neoplasm | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Lung neoplasm malignant | 4/1721 (0.2%) | 5/1718 (0.3%) | ||
| Metastases to central nervous system | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Metastases to peritoneum | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Myelofibrosis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Neoplasm malignant | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Neoplasm prostate | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Ovarian cancer | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Pancreatic carcinoma | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Prostate cancer | 3/1721 (0.2%) | 1/1718 (0.1%) | ||
| Prostatic adenoma | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Rectal cancer | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Rectal neoplasm | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Renal cancer | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Salivary gland adenoma | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Squamous cell carcinoma of skin | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Nervous system disorders | ||||
| Amyotrophic lateral sclerosis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Brain injury | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Cerebral haemorrhage | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Cerebral infarction | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| Cerebral ischaemia | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Cerebral thrombosis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Cerebrovascular accident | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| Coma | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Depressed level of consciousness | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Dizziness | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Grand mal convulsion | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Haemorrhage intracranial | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Headache | 2/1721 (0.1%) | 0/1718 (0%) | ||
| Hypoglycaemic coma | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Hypoxic-ischaemic encephalopathy | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Intracranial aneurysm | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Ischaemic stroke | 2/1721 (0.1%) | 0/1718 (0%) | ||
| Lacunar infarction | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Memory impairment | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Peripheral sensorimotor neuropathy | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Peripheral sensory neuropathy | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Presyncope | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Sensory loss | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Spinal cord compression | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Syncope | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Transient ischaemic attack | 2/1721 (0.1%) | 4/1718 (0.2%) | ||
| Vascular encephalopathy | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Psychiatric disorders | ||||
| Anxiety | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Completed suicide | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Confusional state | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Depression | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Renal and urinary disorders | ||||
| Bladder neck obstruction | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Haematuria | 2/1721 (0.1%) | 0/1718 (0%) | ||
| Nephrotic syndrome | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Renal failure | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Renal failure acute | 3/1721 (0.2%) | 0/1718 (0%) | ||
| Urethral stenosis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Urinary retention | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 2/1721 (0.1%) | 3/1718 (0.2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory distress syndrome | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Acute respiratory failure | 4/1721 (0.2%) | 2/1718 (0.1%) | ||
| Apnoea | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Chronic obstructive pulmonary disease | 147/1721 (8.5%) | 121/1718 (7%) | ||
| Cough | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Dyspnoea | 12/1721 (0.7%) | 4/1718 (0.2%) | ||
| Haemoptysis | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Hydrothorax | 0/1721 (0%) | 2/1718 (0.1%) | ||
| Hypercapnia | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| Hypoxia | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Interstitial lung disease | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Laryngeal oedema | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Lung disorder | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Lung infiltration | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Oropharyngeal pain | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Pleural effusion | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Pleurisy | 2/1721 (0.1%) | 2/1718 (0.1%) | ||
| Pneumonia aspiration | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Pneumothorax | 4/1721 (0.2%) | 2/1718 (0.1%) | ||
| Productive cough | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Pulmonary embolism | 1/1721 (0.1%) | 3/1718 (0.2%) | ||
| Pulmonary oedema | 2/1721 (0.1%) | 0/1718 (0%) | ||
| Respiratory acidosis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Respiratory failure | 4/1721 (0.2%) | 6/1718 (0.3%) | ||
| Sleep apnoea syndrome | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Sputum increased | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Angioedema | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Vascular disorders | ||||
| Aortic aneurysm | 2/1721 (0.1%) | 0/1718 (0%) | ||
| Aortic stenosis | 2/1721 (0.1%) | 0/1718 (0%) | ||
| Circulatory collapse | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Deep vein thrombosis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Hypertension | 2/1721 (0.1%) | 1/1718 (0.1%) | ||
| Hypertensive crisis | 1/1721 (0.1%) | 1/1718 (0.1%) | ||
| Hypertensive emergency | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Hypotension | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Peripheral arterial occlusive disease | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Peripheral artery stenosis | 1/1721 (0.1%) | 0/1718 (0%) | ||
| Peripheral ischaemia | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Phlebitis | 0/1721 (0%) | 1/1718 (0.1%) | ||
| Varicose vein | 0/1721 (0%) | 1/1718 (0.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| IndIndacaterol | Tiotropium | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 890/1721 (51.7%) | 793/1718 (46.2%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 26/1721 (1.5%) | 43/1718 (2.5%) | ||
| General disorders | ||||
| Pyrexia | 19/1721 (1.1%) | 26/1718 (1.5%) | ||
| Infections and infestations | ||||
| Bronchitis | 39/1721 (2.3%) | 34/1718 (2%) | ||
| Influenza | 38/1721 (2.2%) | 45/1718 (2.6%) | ||
| Lower respiratory tract infection | 125/1721 (7.3%) | 98/1718 (5.7%) | ||
| Nasopharyngitis | 118/1721 (6.9%) | 101/1718 (5.9%) | ||
| Upper respiratory tract infection | 70/1721 (4.1%) | 63/1718 (3.7%) | ||
| Upper respiratory tract infection bacterial | 139/1721 (8.1%) | 127/1718 (7.4%) | ||
| Urinary tract infection | 31/1721 (1.8%) | 26/1718 (1.5%) | ||
| Viral upper respiratory tract infection | 91/1721 (5.3%) | 65/1718 (3.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 39/1721 (2.3%) | 40/1718 (2.3%) | ||
| Nervous system disorders | ||||
| Headache | 53/1721 (3.1%) | 49/1718 (2.9%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 668/1721 (38.8%) | 591/1718 (34.4%) | ||
| Cough | 107/1721 (6.2%) | 56/1718 (3.3%) | ||
| Dyspnoea | 56/1721 (3.3%) | 50/1718 (2.9%) | ||
| Vascular disorders | ||||
| Hypertension | 63/1721 (3.7%) | 48/1718 (2.8%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00845728
Other Study ID Numbers:
- CQAB149B2348
- 2008-007944-33
First Posted:
Feb 18, 2009
Last Update Posted:
Nov 19, 2013
Last Verified:
Sep 1, 2013