Phase 2
Completed N=50
Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT00403845 ↗Enrolled (actual)
50
Serious AEs
0.5%
Results posted
Aug 2011
Primary outcomePrimary: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2 — 1.49; 1.48; 1.45; 1.33 Liters
Summary
The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2 |
1.49; 1.48; 1.45; 1.33 | — |
| SECONDARY Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 |
1.58; 1.57; 1.54; 1.42 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2 |
1.47; 1.48; 1.46; 1.36; 1.50; 1.50 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2 |
1.50; 1.49; 1.46; 1.32 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female Japanese aged 40 to 75 years old
- Moderate to severe chronic obstructive pulmonary disease (COPD) with smoking history of at least 20 pack years
Exclusion Criteria
- History of hospitalization for COPD exacerbation within past 6 months
- Use of long-term oxygen therapy
- History of asthma
- Respiratory tract infection within past 1 month
- Consistently very high or low blood sugar
- Clinically abnormal laboratory values or significant condition
- History of heart failure or heart attack within past 6 months
- History of long QT syndrome or long QT interval in electrocardiogram recorded at screening
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00403845). 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.