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Trial record 89 of 10796 for:    Placebo AND once

Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

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ClinicalTrials.gov Identifier: NCT00393458
Recruitment Status : Completed
First Posted : October 27, 2006
Results First Posted : August 18, 2011
Last Update Posted : August 18, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Indacaterol
Drug: Formoterol
Drug: Placebo to indacaterol
Drug: Placebo to formoterol
Enrollment 1732
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Indacaterol 300 μg Plus Placebo to Formoterol Indacaterol 600 μg Plus Placebo to Formoterol Formoterol 12 μg Plus Placebo to Indacaterol Placebo to Indacaterol Plus Placebo to Formoterol
Hide Arm/Group Description Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Period Title: Overall Study
Started 437 428 435 432
Exposed to Study Medication or Placebo 437 425 434 432
Completed 338 326 323 295
Not Completed 99 102 112 137
Reason Not Completed
Adverse Event             35             24             40             35
Subject withdrew consent             27             40             33             50
Unsatisfactory therapeutic effect             12             9             12             30
Protocol deviation             11             11             11             10
Administrative problems             7             8             5             2
Lost to Follow-up             5             6             5             3
Abnormal laboratory value(s)             1             1             0             0
Death             1             1             5             5
Abnormal test procedure result(s)             0             1             1             2
Subject no longer requires study drug             0             1             0             0
Arm/Group Title Indacaterol 300 μg Plus Placebo to Formoterol Indacaterol 600 μg Plus Placebo to Formoterol Formoterol 12 μg Plus Placebo to Indacaterol Placebo to Indacaterol Plus Placebo to Formoterol Total
Hide Arm/Group Description Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 437 425 434 432 1728
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 437 participants 425 participants 434 participants 432 participants 1728 participants
63.9  (8.57) 62.9  (8.74) 63.6  (8.49) 63.2  (8.28) 63.4  (8.52)
[1]
Measure Description: Demographic data are based on all subjects in the safety population, which includes all patients who received at least 1 dose of study drug. Three patients in the indacaterol 600 μg plus placebo to formoterol and one patient in the formoterol 12 μg plus placebo to indacaterol group were not exposed to any study treatment.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 437 participants 425 participants 434 participants 432 participants 1728 participants
Female
86
  19.7%
98
  23.1%
86
  19.8%
80
  18.5%
350
  20.3%
Male
351
  80.3%
327
  76.9%
348
  80.2%
352
  81.5%
1378
  79.7%
1.Primary Outcome
Title Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
Hide Description FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame Week 12 + 1 day, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.
Arm/Group Title Indacaterol 300 μg Plus Placebo to Formoterol Indacaterol 600 μg Plus Placebo to Formoterol Formoterol 12 μg Plus Placebo to Indacaterol Placebo to Indacaterol Plus Placebo to Formoterol
Hide Arm/Group Description:
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Overall Number of Participants Analyzed 389 374 379 371
Least Squares Mean (Standard Error)
Unit of Measure: Liters
1.48  (0.012) 1.48  (0.013) 1.38  (0.013) 1.31  (0.013)
2.Secondary Outcome
Title Percentage of Days of Poor Control During 52 Weeks of Treatment
Hide Description Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame Baseline to end of study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.
Arm/Group Title Indacaterol 300 μg Plus Placebo to Formoterol Indacaterol 600 μg Plus Placebo to Formoterol Formoterol 12 μg Plus Placebo to Indacaterol Placebo to Indacaterol Plus Placebo to Formoterol
Hide Arm/Group Description:
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Overall Number of Participants Analyzed 386 370 377 366
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
33.6  (1.43) 30.0  (1.46) 33.5  (1.45) 38.3  (1.47)
Time Frame Safety population: All patients who received at least 1 dose of study drug.
Adverse Event Reporting Description Baseline to the end of the study (Week 52)
 
Arm/Group Title Indacaterol 300 μg Plus Placebo to Formoterol Indacaterol 600 μg Plus Placebo to Formoterol Formoterol 12 μg Plus Placebo to Indacaterol Placebo to Indacaterol Plus Placebo to Formoterol
Hide Arm/Group Description Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
All-Cause Mortality
Indacaterol 300 μg Plus Placebo to Formoterol Indacaterol 600 μg Plus Placebo to Formoterol Formoterol 12 μg Plus Placebo to Indacaterol Placebo to Indacaterol Plus Placebo to Formoterol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indacaterol 300 μg Plus Placebo to Formoterol Indacaterol 600 μg Plus Placebo to Formoterol Formoterol 12 μg Plus Placebo to Indacaterol Placebo to Indacaterol Plus Placebo to Formoterol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   63/437 (14.42%)   51/425 (12.00%)   69/434 (15.90%)   48/432 (11.11%) 
Blood and lymphatic system disorders         
Anaemia  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Cardiac disorders         
Acute myocardial infarction  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Angina pectoris  1  1/437 (0.23%)  1/425 (0.24%)  0/434 (0.00%)  1/432 (0.23%) 
Angina unstable  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Atrial fibrillation  1  3/437 (0.69%)  0/425 (0.00%)  1/434 (0.23%)  1/432 (0.23%) 
Atrial flutter  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  1/432 (0.23%) 
Atrial tachycardia  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Atrioventricular block  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Cardiac arrest  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  2/432 (0.46%) 
Cardiac failure  1  1/437 (0.23%)  1/425 (0.24%)  1/434 (0.23%)  0/432 (0.00%) 
Cardiac failure congestive  1  2/437 (0.46%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Cardiomyopathy  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Coronary artery disease  1  0/437 (0.00%)  3/425 (0.71%)  0/434 (0.00%)  0/432 (0.00%) 
Ischaemic cardiomyopathy  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Microvascular angina  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Myocardial infarction  1  1/437 (0.23%)  2/425 (0.47%)  1/434 (0.23%)  1/432 (0.23%) 
Myocardial ischaemia  1  2/437 (0.46%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Palpitations  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Pericarditis  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Sinus arrhythmia  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Sinus bradycardia  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Stress cardiomyopathy  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Eye disorders         
Anterior capsule contraction  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Cataract  1  2/437 (0.46%)  0/425 (0.00%)  2/434 (0.46%)  1/432 (0.23%) 
Macular degeneration  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Retinal artery occlusion  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Gastrointestinal disorders         
Abdominal pain upper  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Appendicitis perforated  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Colonic polyp  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Duodenal ulcer  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Femoral hernia  1  1/437 (0.23%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Gastric haemorrhage  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Gastric ulcer  1  0/437 (0.00%)  1/425 (0.24%)  1/434 (0.23%)  0/432 (0.00%) 
Gastric ulcer haemorrhage  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Gastrointestinal haemorrhage  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  1/432 (0.23%) 
Gastrointestinal necrosis  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Inguinal hernia  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  2/432 (0.46%) 
Mallory-Weiss syndrome  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Pancreatitis  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Pancreatitis acute  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Swollen tongue  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
General disorders         
Chest pain  1  1/437 (0.23%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Hyperthermia  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Non-cardiac chest pain  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Sudden death  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  3/432 (0.69%) 
Hepatobiliary disorders         
Cholecystitis acute  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Cholelithiasis  1  1/437 (0.23%)  0/425 (0.00%)  1/434 (0.23%)  2/432 (0.46%) 
Hepatitis alcoholic  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Immune system disorders         
Contrast media allergy  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Infections and infestations         
Appendicitis  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Bronchitis  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Erysipelas  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Gastroenteritis  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Lower respiratory tract infection  1  2/437 (0.46%)  2/425 (0.47%)  5/434 (1.15%)  3/432 (0.69%) 
Lower respiratory tract infection bacterial  1  1/437 (0.23%)  0/425 (0.00%)  2/434 (0.46%)  0/432 (0.00%) 
Nasopharyngitis  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Otitis media chronic  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Perianal abscess  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Pneumonia  1  3/437 (0.69%)  2/425 (0.47%)  5/434 (1.15%)  2/432 (0.46%) 
Postoperative wound infection  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Pulmonary tuberculosis  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Pyothorax  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Respiratory tract infection  1  0/437 (0.00%)  1/425 (0.24%)  2/434 (0.46%)  0/432 (0.00%) 
Septic shock  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Upper respiratory tract infection  1  0/437 (0.00%)  0/425 (0.00%)  3/434 (0.69%)  0/432 (0.00%) 
Upper respiratory tract infection bacterial  1  4/437 (0.92%)  0/425 (0.00%)  5/434 (1.15%)  4/432 (0.93%) 
Viral infection  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Viral upper respiratory tract infection  1  1/437 (0.23%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Injury, poisoning and procedural complications         
Cardiac procedure complication  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Clavicle fracture  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Femoral neck fracture  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Foot fracture  1  0/437 (0.00%)  2/425 (0.47%)  0/434 (0.00%)  1/432 (0.23%) 
Hip fracture  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Humerus fracture  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Lower limb fracture  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Multiple fractures  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Pneumothorax traumatic  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Rib fracture  1  2/437 (0.46%)  1/425 (0.24%)  1/434 (0.23%)  0/432 (0.00%) 
Road traffic accident  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Tendon rupture  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Upper limb fracture  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Wrist fracture  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Investigations         
Blood creatine increased  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Blood urea increased  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Colonoscopy  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Electrocardiogram QT prolonged  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Laboratory test abnormal  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Metabolism and nutrition disorders         
Hyperglycaemia  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Hypokalaemia  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Intervertebral disc protrusion  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Osteoarthritis  1  1/437 (0.23%)  0/425 (0.00%)  1/434 (0.23%)  1/432 (0.23%) 
Osteochondrosis  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Rheumatoid arthritis  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Rotator cuff syndrome  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Benign neoplasm of bladder  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Benign soft tissue neoplasm  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Bladder papilloma  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Breast cancer  1  0/437 (0.00%)  1/425 (0.24%)  1/434 (0.23%)  0/432 (0.00%) 
Bronchial carcinoma  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Carcinoid tumour of the small bowel  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Cervix carcinoma stage 0  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Colon cancer  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Gastric cancer  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  2/432 (0.46%) 
Laryngeal cancer  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Laryngeal neoplasm  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Lung neoplasm malignant  1  0/437 (0.00%)  1/425 (0.24%)  1/434 (0.23%)  1/432 (0.23%) 
Metastases to bone  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Non-small cell lung cancer stage I  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Oesophageal carcinoma  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Pancreatic carcinoma  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Papilloma  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Prostate cancer  1  2/437 (0.46%)  1/425 (0.24%)  1/434 (0.23%)  0/432 (0.00%) 
Rectal cancer  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Skin cancer  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Tracheal cancer  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Nervous system disorders         
Brain injury  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Carotid artery stenosis  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Cerebral infarction  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Cerebral ischaemia  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Cerebrovascular accident  1  0/437 (0.00%)  1/425 (0.24%)  1/434 (0.23%)  0/432 (0.00%) 
Convulsion  1  0/437 (0.00%)  0/425 (0.00%)  2/434 (0.46%)  0/432 (0.00%) 
Facial palsy  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Grand mal convulsion  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Loss of consciousness  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Presyncope  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Syncope  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Vertebrobasilar insufficiency  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Psychiatric disorders         
Alcohol withdrawal syndrome  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Anxiety  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Depression  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Proteinuria  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Renal colic  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Renal failure acute  1  1/437 (0.23%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Urinary incontinence  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  2/432 (0.46%) 
Respiratory, thoracic and mediastinal disorders         
Acute pulmonary oedema  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Apnoea  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Bronchospasm  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Chronic obstructive pulmonary disease  1  18/437 (4.12%)  12/425 (2.82%)  32/434 (7.37%)  20/432 (4.63%) 
Dyspnoea  1  3/437 (0.69%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Emphysema  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Epistaxis  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Hypercapnia  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Lung infiltration  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Obliterative bronchiolitis  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Pneumothorax  1  1/437 (0.23%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Productive cough  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  0/432 (0.00%) 
Pulmonary embolism  1  1/437 (0.23%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Respiratory arrest  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  2/432 (0.46%) 
Respiratory failure  1  3/437 (0.69%)  0/425 (0.00%)  5/434 (1.15%)  1/432 (0.23%) 
Surgical and medical procedures         
Haemorrhoid operation  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Vascular disorders         
Aortic aneurysm  1  2/437 (0.46%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Aortic aneurysm rupture  1  0/437 (0.00%)  0/425 (0.00%)  0/434 (0.00%)  1/432 (0.23%) 
Arterial occlusive disease  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Arteriosclerosis obliterans  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Femoral artery occlusion  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Hypertension  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Hypertensive crisis  1  0/437 (0.00%)  0/425 (0.00%)  2/434 (0.46%)  0/432 (0.00%) 
Iliac artery occlusion  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Peripheral ischaemia  1  0/437 (0.00%)  1/425 (0.24%)  0/434 (0.00%)  0/432 (0.00%) 
Shock  1  0/437 (0.00%)  0/425 (0.00%)  1/434 (0.23%)  0/432 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Indacaterol 300 μg Plus Placebo to Formoterol Indacaterol 600 μg Plus Placebo to Formoterol Formoterol 12 μg Plus Placebo to Indacaterol Placebo to Indacaterol Plus Placebo to Formoterol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   199/437 (45.54%)   183/425 (43.06%)   164/434 (37.79%)   176/432 (40.74%) 
Infections and infestations         
Lower respiratory tract infection  1  25/437 (5.72%)  21/425 (4.94%)  17/434 (3.92%)  20/432 (4.63%) 
Nasopharyngitis  1  73/437 (16.70%)  80/425 (18.82%)  62/434 (14.29%)  56/432 (12.96%) 
Upper respiratory tract infection bacterial  1  26/437 (5.95%)  25/425 (5.88%)  20/434 (4.61%)  33/432 (7.64%) 
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  23/437 (5.26%)  25/425 (5.88%)  12/434 (2.76%)  6/432 (1.39%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  128/437 (29.29%)  108/425 (25.41%)  112/434 (25.81%)  138/432 (31.94%) 
Cough  1  32/437 (7.32%)  27/425 (6.35%)  17/434 (3.92%)  19/432 (4.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights 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 the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00393458     History of Changes
Other Study ID Numbers: CQAB149B2334
First Submitted: October 25, 2006
First Posted: October 27, 2006
Results First Submitted: July 22, 2011
Results First Posted: August 18, 2011
Last Update Posted: August 18, 2011