Status:
COMPLETED
A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
Lead Sponsor:
Amgen
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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 powder or equivalent
- Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points
Exclusion
- 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)
Key Trial Info
Start Date :
October 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2011
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT01199289
Start Date
October 4 2010
End Date
December 21 2011
Last Update
November 26 2021
Active Locations (49)
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1
Research Site
Encinitas, California, United States
2
Research Site
Huntington Beach, California, United States
3
Research Site
Los Angeles, California, United States
4
Research Site
San Diego, California, United States