Phase 3
Completed N=2,059
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive · Chronic Obstructive Pulmonary Disease · Lung Diseases, Obstructive
Source: ClinicalTrials.gov NCT00463567 ↗
Enrolled (actual)
2,059
Serious AEs
7.6%
Results posted
Aug 2011
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment — 1.46; 1.46; 1.42; 1.28 Liters
Summary
Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment |
1.46; 1.46; 1.42; 1.28 | — |
| SECONDARY The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period |
31.5; 30.8; 31.0; 34.0 | — |
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
- Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:
- Smoking history of at least 20 pack years
- Post-bronchodilator FEV1 15 h a day)
- Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
- Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
- Patients with a history of asthma (with further criteria)
- Patients with Type I or uncontrolled Type II diabetes
- Patients with contraindications for tiotropium
- Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
- Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
- Patients with a history of long QT syndrome or whose QTc interval is prolonged
- Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
- Patients who have had treatment with the investigational drug (with further criteria)
- Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period
- Patients with known history of non compliance to medication
- Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00463567). 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.