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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00403845

First received: November 24, 2006

Last updated: July 22, 2011

Last verified: July 2011

History of Changes

Results First Received: July 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Chronic Obstructive Pulmonary Disease
Interventions:	Drug: Indacaterol 150 μg Drug: Indacaterol 300 μg Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg	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.
Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg	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.
Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg	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.
Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo	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.

Participant Flow for 4 periods

Period 1: Treatment Period 1

	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
STARTED	12	13	11	14
COMPLETED	11	13	11	13
NOT COMPLETED	1	0	0	1
Subject withdrew consent	1	0	0	0
Subject no longer needs study drug	0	0	0	1

Period 2: Treatment Period 2

	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
STARTED	11	13	11	13
COMPLETED	10	13	11	13
NOT COMPLETED	1	0	0	0
Subject withdrew consent	1	0	0	0

Period 3: Treatment Period 3

	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
STARTED	10	13	11	13
COMPLETED	10	13	11	11
NOT COMPLETED	0	0	0	2
Subject withdrew consent	0	0	0	1
Adverse Event	0	0	0	1

Period 4: Treatment Period 4

	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
STARTED	10	13	11	11
COMPLETED	10	13	11	11
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in 4 different sequences. Two capsules of study medication were inhaled in the morning between 8:00 and 10:00 am on Day 1 of each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Description

Entire Study Population

The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in 4 different sequences. Two capsules of study medication were inhaled in the morning between 8:00 and 10:00 am on Day 1 of each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	50
Age [units: years] Mean ± Standard Deviation	67.2 ± 5.94
Gender [units: participants]
Female	4
Male	46

Outcome Measures

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1. 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 [ Time Frame: From 22 to 24 hours post-dose on Day 2 ]

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2. Secondary:

Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 [ Time Frame: From 5 minutes to 4 hours post-dose on Day 1 ]

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3. 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 [ Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 ]

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4. 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 [ Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300

No publications provided by Novartis

Publications automatically indexed to this study:

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.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00403845 History of Changes
Other Study ID Numbers:	CQAB149B1202
Study First Received:	November 24, 2006
Results First Received:	July 22, 2011
Last Updated:	July 22, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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