AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma
1 other identifier
interventional
397
0 countries
N/A
Brief Summary
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Oct 2009
Typical duration for phase_2 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 19, 2009
CompletedFirst Posted
Study publicly available on registry
November 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMarch 23, 2016
February 1, 2016
1.2 years
November 19, 2009
February 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
Baseline to Week 12
Secondary Outcomes (5)
Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)
Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)
Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)
Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)
Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)
Baseline to Week 12
Study Arms (2)
AMG 853
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Males or females 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 score ≥ 1.5 points
You may not qualify if:
- History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
- Any uncontrolled, clinically significant systemic disease
- Respiratory infection within 4 weeks of the screening visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Busse WW, Wenzel SE, Meltzer EO, Kerwin EM, Liu MC, Zhang N, Chon Y, Budelsky AL, Lin J, Lin SL. Safety and efficacy of the prostaglandin D2 receptor antagonist AMG 853 in asthmatic patients. J Allergy Clin Immunol. 2013 Feb;131(2):339-45. doi: 10.1016/j.jaci.2012.10.013. Epub 2012 Nov 20.
PMID: 23174659BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2009
First Posted
November 23, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
March 23, 2016
Record last verified: 2016-02