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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Indacaterol 150 μg

Indacaterol 300 μg

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, COPD, QAB149, indacaterol, long acting β2-agonist

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

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

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

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

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

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.

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

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.

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

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.

Full Information

NCT ID

NCT00403845

First Posted

November 24, 2006

Last Updated

July 22, 2011

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00403845

Brief Title

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

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Indacaterol 150 μg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Indacaterol 300 μg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

From 22 to 24 hours post-dose on Day 2

Secondary Outcome Measure Information:

Title

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

Description

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.

Time Frame

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

Title

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

Description

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.

Time Frame

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

Title

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

Description

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals Japan

Organizational Affiliation

Novartis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Novartis Investigative site

City

Kasukabe

Country

Japan

Facility Name

Novartis Investigator Site

City

Kishiwada

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurume

Country

Japan

Facility Name

Novartis Investigative Site

City

Obihiro

Country

Japan

Facility Name

Novartis Investigative Site

City

Sagamihara

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo

Country

Japan

Facility Name

Novartis Investigator Site

City

Tokyo

Country

Japan

Facility Name

Novartis Investigative Site

City

Wakayama

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

21184620

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.

Results Reference

derived

Chronic Obstructive Pulmonary Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial