Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00581945

First received: December 21, 2007

Last updated: June 28, 2011

Last verified: June 2011

History of Changes

Results First Received: May 26, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Basic Science
Condition:	Chronic Obstructive Pulmonary Disease
Interventions:	Drug: Canakinumab 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
Canakinumab	Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
Placebo	Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.

Participant Flow: Overall Study

	Canakinumab	Placebo
STARTED	74	73
COMPLETED	65	63
NOT COMPLETED	9	10
Adverse Event	4	4
Unsatisfactory therapeutic effect	2	0
Withdrawal by Subject	2	6
Death	1	0

Baseline Characteristics

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Reporting Groups

	Description
Canakinumab	Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
Placebo	Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
Total	Total of all reporting groups

Baseline Measures

	Canakinumab	Placebo	Total
Number of Participants [units: participants]	74	73	147
Age [units: years] Mean ± Standard Deviation	63.9 ± 7.70	63.6 ± 7.92	63.7 ± 7.78
Gender [units: participants]
Female	28	31	59
Male	46	42	88

Outcome Measures

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1. Primary:

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, Week 25 and Week 45 ]

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2. Primary:

Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted [ Time Frame: Baseline, Week 25 and Week 45 ]

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3. Primary:

Change From Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline, Week 25 and Week 45 ]

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4. Primary:

Change From Baseline in Slow Vital Capacity (SVC) [ Time Frame: Baseline, Week 25 and Week 45 ]

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5. Primary:

Change From Baseline in Forced Expiratory Flow 25% to 75% [ Time Frame: Baseline, Week 25 and Week 45 ]

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6. Secondary:

Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events [ Time Frame: Adverse events were collected during the 45 week treatment period and the 12 week follow-up period. ]

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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: Novartis Pharmaceuticals
Organization: Study Director
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00581945 History of Changes
Other Study ID Numbers:	CACZ885B2204
Study First Received:	December 21, 2007
Results First Received:	May 26, 2011
Last Updated:	June 28, 2011
Health Authority:	United States: Food and Drug Administration

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