Phase 2
N=335
Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01609478 ↗Enrolled (actual)
335
Serious AEs
1.2%
Results posted
Sep 2014
Primary outcome: Primary: Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85) — 2.190; 2.216; 2.110 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- indacaterol (Drug); placebo (Drug); mometasone furoate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85) |
2.190; 2.216; 2.110 | — |
| SECONDARY Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85) |
1.31; 1.42; 1.32 | — |
| SECONDARY Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment. |
2.169; 2.198; 2.069; 2.180; 2.196; 2.057 | — |
| SECONDARY Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points |
3.342; 3.338; 3.235; 3.372; 3.348; 3.238 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 |
65.608; 66.049; 63.461; 65.602; 67.039; 63.537 | — |
| SECONDARY Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 |
1.420; 1.485; 1.295; 1.449; 1.563; 1.295 | — |
| SECONDARY Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84) |
2.209; 2.274; 2.077; 2.198; 2.253; 2.059 | — |
| SECONDARY Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84) |
2.287; 2.353; 2.172; 2.345; 2.387; 2.165 | — |
| SECONDARY Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment |
1.43; 1.39; 1.55; 1.42; 1.29; 1.46 | — |
| SECONDARY Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period. |
326.98; 335.44; 307.68; 332.96; 345.99; 312.42 | — |
| SECONDARY The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment |
1.08; 0.99; 1.31; 0.54; 0.55; 0.73 | — |
| SECONDARY Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment |
5.52; 5.48; 5.38; 5.64; 5.47; 5.60 | — |
| SECONDARY Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period |
0.315; 0.353; 0.352; 0.421; 0.569; 0.788 | — |
| SECONDARY Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period |
0.7; 0.6; 0.8; 1.0; 0.9; 1.3 | — |
| SECONDARY The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period |
5.6; 5.7; 4.5; 8.4; 8.6; 9.9 | — |
| SECONDARY Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period |
NA; NA; NA | — |
| SECONDARY The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period |
1.9; 1.0; 3.6 | — |
| SECONDARY Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period |
NA; 20; 0; NA; 4; 4 | — |
| SECONDARY Plasma Indacaterol Concentrations at Day 1 and Day 14 |
70.7; 164; 129; 285 | — |
Summary
To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.
Eligibility Criteria
Inclusion Criteria
- Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
- Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
- Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
- Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
- ACQ-5 score ≥ 1.5
Exclusion Criteria
- Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
- Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
- Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01609478). 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.