Phase 2
Completed N=91
Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma
Source: ClinicalTrials.gov NCT01959412 ↗Enrolled (actual)
91
Serious AEs
0.6%
Results posted
May 2015
Primary outcomePrimary: Change From Period Baseline in FEV1 (L) AUC(0-24h) — 0.209; 0.165; 0.154; 0.121 Liters
Summary
The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Period Baseline in FEV1 (L) AUC(0-24h) |
0.209; 0.165; 0.154; 0.121; 0.143; 0.022 | — |
| SECONDARY Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h) |
0.229; 0.180; 0.176; 0.131; 0.125; 0.036 | — |
| SECONDARY Change From Period Baseline in Peak FEV1 (L) |
0.347; 0.290; 0.298; 0.249; 0.259; 0.158 | — |
| SECONDARY Change From Period Baseline in Trough FEV1 (L) |
0.207; 0.162; 0.137; 0.128; 0.161; 0.024 | — |
| SECONDARY Change From Period Baseline in FVC (L) AUC (0-24h) |
0.147; 0.120; 0.118; 0.085; 0.106; 0.016 | — |
Eligibility Criteria
Inclusion Criteria
- Asthma for at least 6 months, using inhaled corticosteroid for at least one month, foreced breath test less than below the normal value of the general population, -show an immediate improvement in breathing when given albuterol
Exclusion Criteria
- patients who have smoked in the past 6 months or are currently smoking, including those who smoked more than a pack of cigarettes a day for at least 10 years, -patients who have a history of life-threatening asthma, -patients who have had an astham attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or ER visit, -patients who have had a respiratory tract infection or worsening asthma between screening or run-in periods, patients requring use of other asthma-related drugs during the trial, other protocol-defined inclusion/exclusion may apply
Data sourced from ClinicalTrials.gov (NCT01959412). 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.