ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Different Doses of Indacaterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01079130
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : August 19, 2011
Last Update Posted : August 19, 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 Asthma
Interventions Drug: Indacaterol
Drug: Salmeterol
Drug: Placebo to Indacaterol
Drug: Placebo to Salmeterol
Enrollment 511
Recruitment Details  
Pre-assignment Details The study consisted of a 14 day run-in period. 511 participants were randomized but only 502 participants received study drug.
Arm/Group Title Indacaterol 18.75 µg Indacaterol 37.5 µg Indacaterol 75 µg Indacaterol 150 µg Salmeterol Placebo
Hide Arm/Group Description Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Period Title: Overall Study
Started 85 85 84 86 86 85
Safety Set: Received Study Drug 84 81 84 85 84 84
Full Analysis Set (FAS) 84 80 [1] 83 85 84 84
Completed 83 78 83 81 78 80
Not Completed 2 7 1 5 8 5
Reason Not Completed
Adverse Event             1             1             0             1             5             1
Administrative problems             1             3             0             0             0             1
Withdrawal by Subject             0             1             0             0             1             3
Protocol deviation             0             2             1             2             0             0
Abnormal test procedure result(s)             0             0             0             0             1             0
Unsatisfactory therapeutic effect             0             0             0             2             0             0
Lost to Follow-up             0             0             0             0             1             0
[1]
2 patients (1 in 37.5 µg;1 in 75 µg group) randomized more than once and were excluded from the FAS.
Arm/Group Title Indacaterol 18.75 µg Indacaterol 37.5 µg Indacaterol 75 µg Indacaterol 150 µg Salmeterol Placebo Total
Hide Arm/Group Description Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 84 81 84 85 84 84 502
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 81 participants 84 participants 85 participants 84 participants 84 participants 502 participants
42.0  (14.64) 41.9  (14.96) 40.2  (14.71) 41.0  (15.20) 40.9  (14.56) 40.6  (14.17) 41.1  (14.65)
[1]
Measure Description: All baseline measures are based on the Full Analysis Set (FAS) that includes all participants who received at least one dose of study drug.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 81 participants 84 participants 85 participants 84 participants 84 participants 502 participants
Female
42
  50.0%
46
  56.8%
49
  58.3%
55
  64.7%
46
  54.8%
40
  47.6%
278
  55.4%
Male
42
  50.0%
35
  43.2%
35
  41.7%
30
  35.3%
38
  45.2%
44
  52.4%
224
  44.6%
1.Primary Outcome
Title Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment
Hide Description Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Time Frame Day 15 (after 2 weeks of treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure. Missing data were imputed last observation carried forward (LOCF).
Arm/Group Title Indacaterol 18.75 µg Indacaterol 37.5 µg Indacaterol 75 µg Indacaterol 150 µg Salmeterol Placebo
Hide Arm/Group Description:
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Overall Number of Participants Analyzed 82 77 82 80 78 81
Least Squares Mean (Standard Error)
Unit of Measure: Liters
2.50  (0.036) 2.52  (0.037) 2.59  (0.036) 2.54  (0.037) 2.54  (0.037) 2.42  (0.036)
2.Secondary Outcome
Title Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment
Hide Description Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Time Frame Day 2 (after 1 day of treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure.
Arm/Group Title Indacaterol 18.75 µg Indacaterol 37.5 µg Indacaterol 75 µg Indacaterol 150 µg Salmeterol Placebo
Hide Arm/Group Description:
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Overall Number of Participants Analyzed 83 77 81 82 79 80
Least Squares Mean (Standard Error)
Unit of Measure: Liters
2.46  (0.026) 2.52  (0.027) 2.54  (0.026) 2.60  (0.026) 2.65  (0.027) 2.45  (0.027)
Time Frame 2 weeks
Adverse Event Reporting Description Safety Population consisting of all participants who received at least one dose of study drug.
 
Arm/Group Title Indacaterol 18.75 µg Indacaterol 37.5 µg Indacaterol 75 µg Indacaterol 150 µg Salmeterol Placebo
Hide Arm/Group Description Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
All-Cause Mortality
Indacaterol 18.75 µg Indacaterol 37.5 µg Indacaterol 75 µg Indacaterol 150 µg Salmeterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indacaterol 18.75 µg Indacaterol 37.5 µg Indacaterol 75 µg Indacaterol 150 µg Salmeterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/81 (0.00%)   0/84 (0.00%)   1/85 (1.18%)   0/84 (0.00%)   0/84 (0.00%) 
Psychiatric disorders             
Substance abuse  1  0/84 (0.00%)  0/81 (0.00%)  0/84 (0.00%)  1/85 (1.18%)  0/84 (0.00%)  0/84 (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 18.75 µg Indacaterol 37.5 µg Indacaterol 75 µg Indacaterol 150 µg Salmeterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/84 (4.76%)   2/81 (2.47%)   12/84 (14.29%)   7/85 (8.24%)   5/84 (5.95%)   4/84 (4.76%) 
Nervous system disorders             
Headache  1  2/84 (2.38%)  2/81 (2.47%)  5/84 (5.95%)  3/85 (3.53%)  4/84 (4.76%)  4/84 (4.76%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  2/84 (2.38%)  0/81 (0.00%)  8/84 (9.52%)  4/85 (4.71%)  1/84 (1.19%)  0/84 (0.00%) 
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 (i.e., 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 Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01079130     History of Changes
Other Study ID Numbers: CQAB149B2357
First Submitted: March 1, 2010
First Posted: March 2, 2010
Results First Submitted: July 22, 2011
Results First Posted: August 19, 2011
Last Update Posted: August 19, 2011