How Different Beta-2 Receptor Genotypes Affect an Asthmatic's Response to Regular Salmeterol Treatment

Completed · Not applicable

Conditions studied: Asthma

In brief

The purpose of the study is to find out how well a long-acting beta agonist like salmeterol works in people with different forms of the same gene. Our hypothesis is that asthmatics with the Arg/Arg genotype will have loss of bronchoprotection against exercise-induced asthma with regular salmeterol treatment, as compared to asthmatics with the Gly/Gly genotype.

Key facts

Study ID

NCT00595361

Run by

Brigham and Women's Hospital

People needed

30

Starts

2008-01-01

Expected to finish

2012-03-01

Last updated by the study team

2017-06-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Both male and female
• 18 to 50 years of age
• Resting FEV1 ≥ 65% of predicted normal
• Exercise-induced bronchoconstriction defined as a decrease in FEV1 of ≥ 20% following a standardized exercise challenge when compared to pre-exercise baseline FEV1 value measured 5 minutes before exercise
• Must be Arg/Arg or Gly/Gly genotype

You may not qualify if…

• Long-acting beta agonist use within 12 weeks of the first exercise challenge
• Smoking within past 12 months
• Greater than 10-pack years smoking history
• Unresolved signs and/or symptoms of an upper respiratory tract infection within 4 weeks of first exercise challenge
• Asthma exacerbation within 4 weeks of first exercise challenge requiring change in type, dose or frequency of medications and/or an unscheduled visit to an health care provider, including emergency room or hospital
• Subject has exercised or performed strenuous activity within 72 hours of the first exercise challenge
• Subject has been exposed to cold air sufficient to provoke symptoms of bronchospasm within 2 hours of exercise challenge
• In addition to asthma, the subject has an active, acute or chronic pulmonary disorder documented by history, physical examination, or chest x-ray
• Subject has evidence of ischemic, valvular, hypertrophic, familial or other forms of heart disease that would put the subject at risk during exercise testing or that would interfere with the ability to achieve protocol-specified heart rates during exercise testing
• Subject has used systemic corticosteroids within 1 month of first exercise challenge

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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