A Phase 2 interventional study of Indacaterol and Placebo to Indacaterol in Persistent Asthma, sponsored by Novartis Pharmaceuticals. Completed at 30 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-17.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 191 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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.
Drug: Indacaterol
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.
Drug: Indacaterol · Drug: Placebo to Indacaterol
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.
Drug: Indacaterol · Drug: Placebo to Indacaterol
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.
Drug: Placebo to Indacaterol
Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.
Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment
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
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
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
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
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
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
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
| Milestone | Indacaterol 37.5 µg (Twice a Day) | Indacaterol 75 µg (Once a Day) | Indacaterol 150 µg (Every Other Day) | Placebo |
|---|---|---|---|---|
| Started | 48 | 48 | 48 | 47 |
| Pd & safety sets: received study drug | 48 | 47 | 48 | 46 |
| Completed | 46 | 46 | 42 | 41 |
| Not completed | 2 | 2 | 6 | 6 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 |
| Withdrew: Abnormal test procedure result(s) | 0 | 1 | 2 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 |
| Withdrew: Administrative problems | 0 | 1 | 0 | 1 |
| Withdrew: Protocol deviation | 2 | 0 | 0 | 0 |
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.
| Liters | Indacaterol 37.5 µg (Twice a Day) | Indacaterol 75 µg (Once a Day) | Indacaterol 150 µg (Every Other Day) | Placebo |
|---|---|---|---|---|
| Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment | 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) |
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.
| Liters | Indacaterol 37.5 µg (Twice a Day) | Indacaterol 75 µg (Once a Day) | Placebo |
|---|---|---|---|
| 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 | 0.196 (0.127 to 0.266) | 0.198 (0.127 to 0.269) | 0.030 (-0.044 to 0.103) |
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.
| Liters | Indacaterol 75 µg (Once a Day) | Indacaterol 150 µg (Every Other Day) | Placebo |
|---|---|---|---|
| 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 | 0.218 (0.148 to 0.288) | 0.198 (0.135 to 0.260) | 0.059 (-0.012 to 0.129) |
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.
| Liters | Indacaterol 37.5 µg (Twice a Day) | Indacaterol 75 µg (Once a Day) | Placebo |
|---|---|---|---|
| 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 | 0.245 (0.170 to 0.319) | 0.243 (0.163 to 0.317) | 0.059 (-0.018 to 0.137) |
Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Indacaterol 37.5 ug (Twice a Day) | — | 0/48 (0%) | 7/48 (14.6%) |
| Indacaterol 75 ug (Once a Day) | — | 0/47 (0%) | 8/47 (17%) |
| Indacaterol 150 ug (Every Other Day) | — | 1/48 (2.1%) | 11/48 (22.9%) |
| Placebo | — | 0/46 (0%) | 8/46 (17.4%) |
| Event | Indacaterol 37.5 ug (Twice a Day) | Indacaterol 75 ug (Once a Day) | Indacaterol 150 ug (Every Other Day) | Placebo |
|---|---|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/48 | 0/47 | 1/48 | 0/46 |
| Event | Indacaterol 37.5 ug (Twice a Day) | Indacaterol 75 ug (Once a Day) | Indacaterol 150 ug (Every Other Day) | Placebo |
|---|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 3/48 | 3/47 | 7/48 | 1/46 |
| HeadacheNervous system disorders | 3/48 | 2/47 | 3/48 | 6/46 |
| NasopharyngitisInfections and infestations | 1/48 | 2/47 | 0/48 | 0/46 |
| DizzinessNervous system disorders | 0/48 | 2/47 | 1/48 | 1/46 |
| VomitingGastrointestinal disorders | 0/48 | 1/47 | 2/48 | 0/46 |
| Age Continuous(years) | Indacaterol 37.5 µg (Twice a Day) | Indacaterol 75 µg (Once a Day) | Indacaterol 150 µg (Every Other Day) | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 37.4 ± 11.0 | 41.1 ± 14.7 | 42.0 ± 12.2 | 40.8 ± 12.7 | 40.3 ± 12.7 |
| Sex: Female, Male(Participants) | Indacaterol 37.5 µg (Twice a Day) | Indacaterol 75 µg (Once a Day) | Indacaterol 150 µg (Every Other Day) | Placebo | Total |
|---|---|---|---|---|---|
| Female | 21 | 24 | 16 | 18 | 79 |
| Male | 27 | 23 | 32 | 28 | 110 |
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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