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Study Complete
Sponsor ID
20060161

Phase II Study to Evaluate the Efficacy of AMG 317

Sponsor ID
20060161
Clinicaltrials.gov ID
NCT00436670
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.

Additional Study Details

Phase
Phase 2
Product
AMG 317
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
294
Additional Study Details

Protocol Summary

Primary Outcome Measures

The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.

Timeframe: 12 weeks

Secondary Outcome Measures

Change from baseline in frequency of rescue beta agonist use during week 12

Timeframe: 12 weeks

Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)

Timeframe: 12 weeks

Change in pre and post bronchodilator FEV1 at week 12 from baseline

Timeframe: 12 weeks

Number of asthma symptom-free days

Timeframe: 16 weeks

Change from baseline in daily asthma symptoms during week 12

Timeframe: 12 weeks

Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs

Timeframe: 16 weeks

Change in AQLQ score at week 12 from baseline

Timeframe: 12 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18 - 65 Years
Condition
  • Asthma
    • Sex
    All
    Trial Dates
    Mar 2007 - Sep 2008
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Males or females 18 to 65 years of age at the time of screening - Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening - At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months - Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Stable ICS dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. Must have used ICS for at least the last 3 consecutive months before screening - If receiving allergen immunotherapy, a stable dose for > 3 months before screening and anticipated to remain stable for the duration of the study - Positive to skin prick or RAST - Ongoing asthma symptoms with ACQ score at screening and baseline ≥ 1.5 points - Nonsmoker or ex-smoker with < 10 pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year ago
    Exclusion Criteria:
    - Acute asthma exacerbation requiring emergency room (ER) treatment or hospitalization within 3 months - History of endotracheal intubation for asthma-related exacerbation within 3 years of screening - Respiratory illness within 4 weeks of screening - History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma - Received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in visit. - Leukotriene antagonists within 2 weeks before first run-in visit - Oral or parenteral corticosteroids within 6 weeks before first run-in visit - Live/attenuated vaccinations within 4 weeks of screening or during the study - Any uncontrolled, clinically significant systemic disease (eg, chronic renal failure, uncontrolled hypertension, liver disease)