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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01199289

Run by

Amgen

People needed

315

Starts

2010-10-04

Expected to finish

2011-12-21

Last updated by the study team

2021-11-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Stockbridge, Georgia, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — North Dartmouth, Massachusetts, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Bozeman, Montana, United States
• Research Site — Bellevue, Nebraska, United States
• Research Site — Skillman, New Jersey, United States
• Research Site — Rockville Centre, New York, United States
• Research Site — High Point, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Lake Oswego, Oregon, United States
• Research Site — Medford, Oregon, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — El Paso, Texas, United States
• Research Site — Madison, Wisconsin, United States
• Research Site — Feldbach, Austria
• Research Site — Hallein, Austria
• Research Site — Vienna, Austria

Full record on ClinicalTrials.gov

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