Phase 3
Completed N=449
Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01604278 ↗Enrolled (actual)
449
Serious AEs
2.2%
Results posted
Nov 2014
Primary outcomePrimary: Trough Forced Expiratory Volume at 1 Second (FEV1) — 1.499; 1.436 Liters
Summary
This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume at 1 Second (FEV1) |
1.499; 1.436 | — |
| SECONDARY FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose |
1.641; 1.530 | — |
| SECONDARY Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks |
1.702; 1.596 | — |
| SECONDARY FEV1 at Individual Time-points |
1.544; 1.467; 1.589; 1.479; 1.626; 1.506 | — |
| SECONDARY Forced Vital Capacity (FVC) at Individual Time-points |
3.214; 3.135; 3.295; 3.182; 3.325; 3.200 | — |
| SECONDARY Inspiratory Capacity (IC) at Individual Time-points |
2.493; 2.434; 2.587; 2.478; 2.557; 2.475 | — |
| SECONDARY Change From Baseline in Mean Daily Number of Puffs of Rescue Medication |
-1.9; -1.8 | — |
| SECONDARY Transitional Dyspnea Index (TDI) Focal Score |
2.506; 2.012 | — |
| SECONDARY Change From Baseline in Mean Daily Total and Individual Symptom Scores |
-1.2; -1.1; -0.3; -0.2; -0.2; -0.2 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
85; 75; 5; 5; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
- Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening.
- Current or ex-smokers who have a smoking history of at least 10 pack years
- Symptomatic patients according to daily diary data.
Exclusion Criteria
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential unless using adequate contraception.
- Patients with Type I or uncontrolled Type II diabetes.
- Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
- Patients with paroxysmal (e.g. intermittent) atrial fibrillation
- Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01604278). 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.