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Efficacy, Safety and Pharmacokinetics of Different Regimens 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: NCT01156844
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : August 17, 2011
Last Update Posted : August 17, 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 Persistent Asthma
Interventions Drug: Indacaterol
Drug: Placebo to Indacaterol
Enrollment 191
Recruitment Details  
Pre-assignment Details The study consisted of a 21 day screening period, a 14 day run-in period and a baseline assessment day prior to the 16 day treatment period. 1 participant randomized to 75 ug Indacaterol and 1 participant randomized to Placebo did not receive study drug and were not included in the Safety set milestone.
Arm/Group Title Indacaterol 37.5 µg (Twice a Day) Indacaterol 75 µg (Once a Day) Indacaterol 150 µg (Every Other Day) Placebo
Hide Arm/Group Description Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Period Title: Overall Study
Started 48 [1] 48 48 47
PD & Safety Sets: Received Study Drug 48 [2] 47 48 46
Completed 46 46 42 41
Not Completed 2 2 6 6
Reason Not Completed
Adverse Event             0             0             1             1
Abnormal test procedure result(s)             0             1             2             2
Withdrawal by Subject             0             0             2             2
Lost to Follow-up             0             0             1             0
Administrative problems             0             1             0             1
Protocol deviation             2             0             0             0
[1]
Randomized participants.
[2]
PD=Pharmacodynamic
Arm/Group Title Indacaterol 37.5 µg (Twice a Day) Indacaterol 75 µg (Once a Day) Indacaterol 150 µg (Every Other Day) Placebo Total
Hide Arm/Group Description Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 48 47 48 46 189
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 47 participants 48 participants 46 participants 189 participants
37.4  (11.0) 41.1  (14.7) 42.0  (12.2) 40.8  (12.7) 40.3  (12.7)
[1]
Measure Description: Baseline measures used the Safety Set that included 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 48 participants 47 participants 48 participants 46 participants 189 participants
Female
21
  43.8%
24
  51.1%
16
  33.3%
18
  39.1%
79
  41.8%
Male
27
  56.3%
23
  48.9%
32
  66.7%
28
  60.9%
110
  58.2%
1.Primary Outcome
Title Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment
Hide Description Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Time Frame Baseline to week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.
Arm/Group Title Indacaterol 37.5 µg (Twice a Day) Indacaterol 75 µg (Once a Day) Indacaterol 150 µg (Every Other Day) Placebo
Hide Arm/Group Description:
Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Overall Number of Participants Analyzed 48 47 48 46
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Liters
0.156
(0.083 to 0.228)
0.197
(0.125 to 0.269)
0.199
(0.125 to 0.272)
-0.005
(-0.080 to 0.071)
2.Primary Outcome
Title Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment
Hide Description Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Time Frame Baseline, 0-24 hours post dose week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.
Arm/Group Title Indacaterol 37.5 µg (Twice a Day) Indacaterol 75 µg (Once a Day) Placebo
Hide Arm/Group Description:
Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
Overall Number of Participants Analyzed 48 47 46
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Liters
0.196
(0.127 to 0.266)
0.198
(0.127 to 0.269)
0.030
(-0.044 to 0.103)
3.Primary Outcome
Title Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment
Hide Description Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Time Frame Baseline, 0 to 48 hours post dose week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.
Arm/Group Title Indacaterol 75 µg (Once a Day) Indacaterol 150 µg (Every Other Day) Placebo
Hide Arm/Group Description:
Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
Overall Number of Participants Analyzed 47 48 46
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Liters
0.218
(0.148 to 0.288)
0.198
(0.135 to 0.260)
0.059
(-0.012 to 0.129)
4.Secondary Outcome
Title Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment
Hide Description Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-12 hours) of FEV1 measurements taken at pre-dose to 12 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Time Frame Baseline, 0 to 12 hours post dose week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.
Arm/Group Title Indacaterol 37.5 µg (Twice a Day) Indacaterol 75 µg (Once a Day) Placebo
Hide Arm/Group Description:
Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
Overall Number of Participants Analyzed 48 47 46
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Liters
0.245
(0.170 to 0.319)
0.243
(0.163 to 0.317)
0.059
(-0.018 to 0.137)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population.
 
Arm/Group Title Indacaterol 37.5 ug (Twice a Day) Indacaterol 75 ug (Once a Day) Indacaterol 150 ug (Every Other Day) Placebo
Hide Arm/Group Description Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
All-Cause Mortality
Indacaterol 37.5 ug (Twice a Day) Indacaterol 75 ug (Once a Day) Indacaterol 150 ug (Every Other Day) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Indacaterol 37.5 ug (Twice a Day) Indacaterol 75 ug (Once a Day) Indacaterol 150 ug (Every Other Day) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/47 (0.00%)   1/48 (2.08%)   0/46 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/48 (0.00%)  0/47 (0.00%)  1/48 (2.08%)  0/46 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Indacaterol 37.5 ug (Twice a Day) Indacaterol 75 ug (Once a Day) Indacaterol 150 ug (Every Other Day) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/48 (14.58%)   8/47 (17.02%)   11/48 (22.92%)   8/46 (17.39%) 
Gastrointestinal disorders         
Vomiting  1  0/48 (0.00%)  1/47 (2.13%)  2/48 (4.17%)  0/46 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  1/48 (2.08%)  2/47 (4.26%)  0/48 (0.00%)  0/46 (0.00%) 
Nervous system disorders         
Dizziness  1  0/48 (0.00%)  2/47 (4.26%)  1/48 (2.08%)  1/46 (2.17%) 
Headache  1  3/48 (6.25%)  2/47 (4.26%)  3/48 (6.25%)  6/46 (13.04%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/48 (6.25%)  3/47 (6.38%)  7/48 (14.58%)  1/46 (2.17%) 
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01156844    
Other Study ID Numbers: CQAB149B2223
2010-018481-22 ( EudraCT Number )
First Submitted: June 30, 2010
First Posted: July 5, 2010
Results First Submitted: July 22, 2011
Results First Posted: August 17, 2011
Last Update Posted: August 17, 2011