Dose Ranging Study for Indacaterol in Japanese Asthma Patients

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00403754

First received: November 23, 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, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Indacaterol Drug: Placebo Drug: Salmeterol

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
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A 14 day eligibility screening period insured all participants were stable on their permissible asthma treatment before proceeding onto core study drug treatment.

Reporting Groups

	Description
Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol	In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol	In treatment period 1: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol	In treatment period 1: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t
Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol	In treatment period 1: patients received 2 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t

Participant Flow for 5 periods

Period 1: Core Treatment Period 1

	Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol	Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol	Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol	Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol
STARTED	11	10	9	11
COMPLETED	11	9	9	11
NOT COMPLETED	0	1	0	0
Withdrawal by Subject	0	1	0	0

Period 2: Core Treatment Period 2

	Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol	Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol	Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol	Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol
STARTED	11	9	9	11
COMPLETED	11	9	8	11
NOT COMPLETED	0	0	1	0
Lack of Efficacy	0	0	1	0

Period 3: Core Treatment Period 3

	Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol	Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol	Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol	Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol
STARTED	11	9	8	11
COMPLETED	11	9	8	11
NOT COMPLETED	0	0	0	0

Period 4: Core Treatment Period 4

	Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol	Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol	Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol	Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol
STARTED	11	9	8	11
COMPLETED	11	9	8	11
NOT COMPLETED	0	0	0	0

Period 5: Open Label: Salmeterol

	Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol	Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol	Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol	Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol
STARTED	11	9	8	11
COMPLETED	11	9	8	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 the 4 different sequences of the core phase. Two capsules of study medication were inhaled in the morning on Day 1 of each treatment period. Following the core phase patients continued to the Salmeterol open label phase. Salmeterol was inhaled via a Diskus inhalation device 50 µg in the morning and 50 µg 12 hours post initial dose on Day 1. Patients received each treatment only once. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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 the 4 different sequences of the core phase. Two capsules of study medication were inhaled in the morning on Day 1 of each treatment period. Following the core phase patients continued to the Salmeterol open label phase. Salmeterol was inhaled via a Diskus inhalation device 50 µg in the morning and 50 µg 12 hours post initial dose on Day 1. Patients received each treatment only once.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	41
Age [units: years] Mean ± Standard Deviation	47.8 ± 14.90
Gender [units: participants]
Female	21
Male	20

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: 22, 23, and 24 hours post-dose on Day 2 ]

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2. 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: 5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2 ]

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3. Secondary:

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

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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 Post-dose on Day 1 to 24 Hours Post-dose on Day 2 [ Time Frame: 5 minutes to 12 hours post-dose on Day 1; and 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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00403754 History of Changes
Other Study ID Numbers:	CQAB149A1202
Study First Received:	November 23, 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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