Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01543828

First received: February 28, 2012

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Results First Received: March 19, 2013

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:	COPD
Interventions:	Drug: indacaterol 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
Indacaterol Then Placebo	In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
Placebo Then Indacaterol	In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.

Participant Flow for 2 periods

Period 1: Treatment 1

	Indacaterol Then Placebo	Placebo Then Indacaterol
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Period 2: Treatment 2

	Indacaterol Then Placebo	Placebo Then Indacaterol
STARTED	20	19 ^[1]
COMPLETED	19	19
NOT COMPLETED	1	0
Lost to Follow-up	1	0

[1]	1 participant completed treatment 1, had an adverse event, and did not receive treatment 2.

Baseline Characteristics

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Reporting Groups

	Description
Indacaterol Then Placebo	In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
Placebo Then Indacaterol	In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
Total	Total of all reporting groups

Baseline Measures

	Indacaterol Then Placebo	Placebo Then Indacaterol	Total
Number of Participants [units: participants]	20	20	40
Age [units: years] Mean ± Standard Deviation	62.2 ± 10.29	60.8 ± 6.90	61.5 ± 8.68
Gender [units: participants]
Female	9	4	13
Male	11	16	27

Outcome Measures

1. Primary:

Time (in Minutes) to Patient's Perception of Onset of Effect [ Time Frame: 5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 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 (i.e., 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

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01543828 History of Changes
Other Study ID Numbers:	CQAB149BUS01
Study First Received:	February 28, 2012
Results First Received:	March 19, 2013
Last Updated:	May 6, 2013
Health Authority:	United States: Institutional Review Board

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