A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT01199289

First received: August 5, 2010

Last updated: September 22, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 5, 2010

Last Updated Date

September 22, 2011

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary objective is to determine if AMG 827 is effective compared to placebo as mesasured by change in Asthma Control Questionnaire (ACQ) composite scores from baseline to week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT01199289 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the efficacy of AMG 827 as measured by Pre- and post-bronchodilator FEV1 (forced expiratory volume in 1 second) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Evaluate the efficacy of AMG 827 as measured by am and pm Peak expiratory flow rate (PEFR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Evaluate the efficacy of AMG 827 as measured by use of rescue Short Acting β-Agonist (SABA) use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Evaluate the efficacy of AMG 827 as measured by daily asthma symptoms (aggregate/night and individual) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Evaluate the efficacy of AMG 827 as measured by Asthma Quality of Life Questionnaire (AQLQ) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma

Brief Summary

The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: AMG 827
210 mg AMG 827 SC
Drug: Placebo
Placebo SC
Drug: AMG 827
140 mg AMG 827 SC
Drug: AMG 827
280 mg AMG 827 SC

Study Arm (s)

Experimental: AMG 827 280 mg
280 mg AMG 827

Intervention: Drug: AMG 827
Placebo Comparator: Placebo
Placebo

Intervention: Drug: Placebo
Experimental: AMG 827 140 mg
140 mg AMG 827

Intervention: Drug: AMG 827
Experimental: AMG 827 210 mg
210 mg AMG 827

Intervention: Drug: AMG 827

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

315

Estimated Completion Date

July 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Men or women 18 to 65 years of age
Percent of predicted FEV1 ≥ 50% and ≤ 80%
At least 12% reversibility over pre-bronchodilator FEV1
Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent.
Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

Exclusion Criteria:

Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Belgium, Canada, Finland, Hungary, Korea, Republic of, Netherlands, Poland, Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT01199289

Other Study ID Numbers ^ICMJE

20090203

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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