Study Complete
Sponsor ID
20090203

A study to evaluate the dosing of AMG 827 for subjects with Inadequately Controlled Asthma

Sponsor ID
20090203
Clinicaltrials.gov ID
NCT01199289
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 827
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
315
Additional Study Details

Protocol Summary

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.

Timeframe: 12 weeks

Secondary Outcome Measures

Evaluate the efficacy of AMG 827 as measured by Pre- and post-bronchodilator FEV1 (forced expiratory volume in 1 second)

Timeframe: 12 weeks

Evaluate the efficacy of AMG 827 as measured by am and pm Peak expiratory flow rate (PEFR)

Timeframe: 12 weeks

Evaluate the efficacy of AMG 827 as measured by use of rescue Short Acting β-Agonist (SABA) use

Timeframe: 12 weeks

Evaluate the efficacy of AMG 827 as measured by daily asthma symptoms (aggregate/night and individual)

Timeframe: 12 weeks

Evaluate the efficacy of AMG 827 as measured by Asthma Quality of Life Questionnaire (AQLQ) score

Timeframe: 12 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Los Angeles, California, United States
Status
Recruiting
Location
Research Site
Huntington Beach, California, United States
Status
Recruiting
Location
Research Site
San Diego, California, United States
Status
Recruiting
Location
Research Site
Stockton, California, United States
Status
Recruiting
Location
Research Site
Encinitas, California, United States
Status
Recruiting
Location
Research Site
Colorado Springs, Colorado, United States
Status
Recruiting
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