Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00403845 | Completed Phase 2 Results

• 1 other identifier: CQAB149B1202
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; COPD; QAB149; indacaterol; long acting β2-agonist

Outcome Measures

Primary Outcomes (1)

• 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

  FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate.

  From 22 to 24 hours post-dose on Day 2

Secondary Outcomes (3)

• Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1

  From 5 minutes to 4 hours post-dose on Day 1

• 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

  From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2

• 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

  From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2

Study Arms (4)

Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg

EXPERIMENTAL

In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg; Drug: Indacaterol 300 μg; Drug: Placebo

Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg

EXPERIMENTAL

In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg; Drug: Indacaterol 300 μg; Drug: Placebo

Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg

EXPERIMENTAL

In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg; Drug: Indacaterol 300 μg; Drug: Placebo

Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo

EXPERIMENTAL

In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg; Drug: Indacaterol 300 μg; Drug: Placebo

Interventions

Indacaterol 150 μg DRUG

Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg; Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg; Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo; Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg

Indacaterol 300 μg DRUG

Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg; Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg; Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo; Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg

Placebo DRUG

Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg; Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg; Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo; Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (8)

Novartis Investigative site

Kasukabe, Japan

Location

Novartis Investigator Site

Kishiwada, Japan

Location

Novartis Investigative Site

Kurume, Japan

Location

Novartis Investigative Site

Obihiro, Japan

Location

Novartis Investigative Site

Sagamihara, Japan

Location

Novartis Investigative Site

Sapporo, Japan

Location

Novartis Investigator Site

Tokyo, Japan

Location

Novartis Investigative Site

Wakayama, Japan

Location

Related Publications (1)

• 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.

  PMID: 21184620 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals Japan

  Novartis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2006
• First Posted: November 27, 2006
• Study Start: December 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 17, 2011
• Results First Posted: August 17, 2011

Record last verified: 2011-07

Locations

JP (8)