Phase 3
Completed N=318
Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks
Source: ClinicalTrials.gov NCT01068600 ↗Enrolled (actual)
318
Serious AEs
2.5%
Results posted
Aug 2011
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment — 1.49; 1.35 Liters
Summary
This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment |
1.49; 1.35 | — |
| SECONDARY Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment |
1.22; 0.76 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:
- Smoking history of at least 10 pack-years
- Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
Exclusion Criteria
- Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to screening
- Patients who have had a respiratory tract infection within 6 weeks prior to screening
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Patients with diabetes Type I or uncontrolled diabetes Type II
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular comorbid conditions
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01068600). 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.