Phase 2
Completed N=41
Dose Ranging Study for Indacaterol in Japanese Asthma Patients
Source: ClinicalTrials.gov NCT00403754 ↗Enrolled (actual)
41
Serious AEs
0.0%
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 — 2.31; 2.28; 2.24; 2.06 Liters
Summary
This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, 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 |
2.31; 2.28; 2.24; 2.06; 2.23 | — |
| 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 |
2.25; 2.20; 2.19; 2.04; 2.13; 2.33 | — |
| SECONDARY Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 |
2.49; 2.44; 2.41; 2.19; 2.39 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2 |
2.35; 2.31; 2.26; 2.04; 2.24 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female Japanese asthmatic patients aged 18 to 75 years old.
Exclusion Criteria
- Patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to the first day of screening or during the screening period.
- Patients who have used tobacco products within 6 months prior to the first day of screening or have a smoking history of greater than 10 pack years.
- Patients with a history of malignancy with the exception of localized basal cell carcinoma of the skin.
- Pregnant or nursing (lactating) women.
- Patients who have had treatment with disallowed medications including investigational drug.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00403754). 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.