Phase 2
Completed N=191
Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
Persistent Asthma
Source: ClinicalTrials.gov NCT01156844 ↗
Enrolled (actual)
191
Serious AEs
0.5%
Results posted
Aug 2011
Primary outcomePrimary: Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment — 0.156; 0.197; 0.199; -0.005 Liters
Summary
This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment |
0.156; 0.197; 0.199; -0.005 | — |
| PRIMARY 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; 0.198; 0.030 | — |
| PRIMARY 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; 0.198; 0.059 | — |
| SECONDARY 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; 0.243; 0.059 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of asthma and:
- Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
- FEV1 ≥50% and ≤90% of predicted normal at screening
- An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI
Exclusion Criteria
- Smoking history of ≥ 10 years
- Patients with a diagnosis of COPD
- Patients who have been previously intubated for a severe asthma exacerbation/ attack
- Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
- Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
- Patients who have had a respiratory tract infection within 6 weeks prior to screening
- Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
- Patients with Type I or uncontrolled Type II diabetes mellitus
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01156844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.