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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01199289
First received: August 5, 2010
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: AMG 827
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 315
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 827 280 mg
280 mg AMG 827
Drug: AMG 827
280 mg AMG 827 SC
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo SC
Experimental: AMG 827 140 mg
140 mg AMG 827
Drug: AMG 827
140 mg AMG 827 SC
Experimental: AMG 827 210 mg
210 mg AMG 827
Drug: AMG 827
210 mg AMG 827 SC

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199289

  Hide Study Locations
Locations
United States, California
Research Site
Encinitas, California, United States
Research Site
Huntington Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
Research Site
Stockton, California, United States
United States, Colorado
Research Site
Colorado Springs, Colorado, United States
United States, Georgia
Research Site
Stockbridge, Georgia, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Massachusetts
Research Site
North Dartmouth, Massachusetts, United States
United States, Missouri
Research Site
St Louis, Missouri, United States
United States, Montana
Research Site
Bozeman, Montana, United States
United States, Nebraska
Research Site
Bellevue, Nebraska, United States
United States, New Jersey
Research Site
Skillman, New Jersey, United States
United States, New York
Research Site
Rockville Centre, New York, United States
United States, North Carolina
Research Site
High Point, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oregon
Research Site
Lake Oswego, Oregon, United States
Research Site
Medford, Oregon, United States
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States
United States, Texas
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Austria
Research Site
Feldbach, Austria
Research Site
Hallein, Austria
Research Site
Wien, Austria
Belgium
Research Site
Bruxelles, Belgium
Research Site
Leuven, Belgium
Research Site
Liege, Belgium
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Canada, Ontario
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Finland
Research Site
Helsinki, Finland
Research Site
Jyväskylä, Finland
Research Site
Turku, Finland
Hungary
Research Site
Edeleny, Hungary
Research Site
Matrahaza, Hungary
Research Site
Tatabanya, Hungary
Research Site
Torokbalint, Hungary
Research Site
Zalaegerszeg - Pozva, Hungary
Korea, Republic of
Research Site
Bucheon-si, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Suwon, Korea, Republic of
Netherlands
Research Site
Rotterdam, Netherlands
Poland
Research Site
Bialystok, Poland
Research Site
Chodziez, Poland
Research Site
Gdansk, Poland
Research Site
Wroclaw, Poland
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Saint Petersburg, Russian Federation
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01199289     History of Changes
Other Study ID Numbers: 20090203
Study First Received: August 5, 2010
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Amgen
chronic inflammatory disease
wheezing

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014