Phase 3
Completed N=3,444
Exacerbation Study
Source: ClinicalTrials.gov NCT00845728 ↗Enrolled (actual)
3,444
Serious AEs
15.1%
Results posted
Nov 2013
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1). — 1.134; 1.145 Liters
Summary
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1). |
1.134; 1.145 | — |
| SECONDARY Rate of COPD Exacerbations |
0.79; 0.61 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
- Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:
- Smoking history of at least 10 pack years, both current and ex-smokers are eligible
- A documented history of at least 1 moderate or severe exacerbation in the previous 12 months
Exclusion Criteria
- Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
- 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 (NCT00845728). 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.