Status:
COMPLETED
Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Asthma Clinical Research Network
Conditions:
Asthma
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethaso...
Detailed Description
BACKGROUND: The purpose of this study is to compare the effects of a long-acting beta agonist in patients with asthma receiving inhaled corticosteroids who express two distinct polymorphisms of the b...
Eligibility Criteria
Inclusion
- Male or female, ages 18 and older
- Clinical history consistent with asthma
- For subjects regularly using inhaled corticosteroids, FEV1 50% of predicted, methacholine PC20 FEV1 16 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol
- For subjects not regularly using inhaled corticosteroids, FEV1 40% of predicted, methacholine PC20 FEV1 8 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol
- Genotype eligibility (determined during screening)
Exclusion
- Smoker (total smoking history must be less than 10 pack years)
- Significant unstable medical condition other than asthma
- History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the past 10 years
- Pregnant or lactating
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00200967
Start Date
December 1 2004
End Date
February 1 2008
Last Update
January 23 2018
Active Locations (7)
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1
University of California, San Diego
San Diego, California, United States, 92103
2
University of California, San Francisco
San Francisco, California, United States, 94143-0130
3
National Jewish Medical & Research Center
Denver, Colorado, United States, 80206
4
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115