Clinical trial NCT00403845: Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, and 600 µg) Delivered Via a Single Dose Dry Powder Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
COPD
QAB149
indacaterol
long acting β2-agonist
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: 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
timeFrame: From 22 to 24 hours post-dose on Day 2
Secondary outcomes:
measure: Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1
timeFrame: From 5 minutes to 4 hours post-dose on Day 1
measure: 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
timeFrame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2
measure: 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
timeFrame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2
Other outcomes:
Locations:
city: Kasukabe
country: Japan
facility: Novartis Investigative site
city: Kishiwada
country: Japan
facility: Novartis Investigator Site
city: Kurume
country: Japan
facility: Novartis Investigative Site
city: Obihiro
country: Japan
facility: Novartis Investigative Site
city: Sagamihara
country: Japan
facility: Novartis Investigative Site
city: Sapporo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigator Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals Japan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hosoe M, Woessner R, Matsushima S, Lawrence D, Kramer B. Efficacy, safety and pharmacokinetics of indacaterol in Caucasian and Japanese patients with chronic obstructive pulmonary disease: a comparison of data from two randomized, placebo-controlled studies. Clin Drug Investig. 2011;31(4):247-55. doi: 10.2165/11586520-000000000-00000.