Phase 3
Completed N=95
Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT00615030 ↗Enrolled (actual)
95
Serious AEs
0.4%
Results posted
Aug 2011
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo — 1.57; 1.37 Liters
Summary
This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full 24-h time period
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo |
1.57; 1.37 | — |
| SECONDARY Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons |
1.56; 1.57; 1.51; 1.46; 1.36; 1.37 | — |
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 chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
- Smoking history of at least 20 pack years
- Post-bronchodilator FEV1 15 h a day)
- Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
- Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
- Patients with history of asthma (with further criteria)
- Patients with Type I or uncontrolled type II diabetes.
- 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
- Patient with a history with long QT syndrome or whose QTc interval is prolonged
- Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structure
- Patients who have had treatment with an investigational drug (with further criteria)
- Patients who have had live attenuated vaccination within 30 days prior to Visit 2, 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 (NCT00615030). 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.