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

This study has been completed.
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital Identifier:
First received: January 7, 2008
Last updated: March 6, 2017
Last verified: March 2017
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.

Condition Intervention
Drug: salmeterol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: The Effect of Beta-2 Adrenergic Polymorphisms on the Bronchoprotective Effects of Regular Salmeterol Treatment in Asthma

Resource links provided by NLM:

Further study details as provided by Elliot Israel, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Comparison of the Maximum Percent Fall in FEV1 After Exercise Challenge at the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients [ Time Frame: 2 weeks ]

Enrollment: 30
Study Start Date: January 2008
Study Completion Date: March 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arg/Arg
Arg/Arg subjects on 2 week salmeterol treatment
Drug: salmeterol
salmeterol 50 micrograms twice daily for 2 weeks
Active Comparator: Gly/Gly
Gly/Gly subjects on 2 week salmeterol treatment
Drug: salmeterol
salmeterol 50 micrograms twice daily for 2 weeks

Detailed Description:

In many patients with asthma, exercise-induced bronchoconstriction is a common and oftentimes limiting characteristic. Inhaled β2-adrenoreceptor agonists like albuterol are the most effective treatments available for the relief of acute asthma symptoms. However, there is evidence that regular use may lead to adverse effects in some patients. Previous studies have shown that polymorphisms of the β2-adrenergic receptor can influence airway responses to regular inhaled beta-agonist treatment.

Pharmacogenetics is the study of how genetic differences influence the variability in patients' responses to therapy, both therapeutic and adverse. Genetic susceptibility and environmental factors both play major roles in the etiology of asthma. The strong familial clustering of asthma has lead to a surge of research into the genetic predisposition of asthma. The aim of the present study is to utilize a double-blinded prospective cohort study to investigate whether genotype-specific effects occur when assessing the duration of protection conferred against exercise-induced bronchoconstriction by regular salmeterol treatment.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00595361

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Elliot Israel, M.D. Asthma Research Center, Brigham and Women's Hospital
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Elliot Israel, MD, Director, Asthma Research Center, Brigham and Women's Hospital Identifier: NCT00595361     History of Changes
Other Study ID Numbers: 2007-P-002199
Study First Received: January 7, 2008
Results First Received: July 16, 2014
Last Updated: March 6, 2017

Keywords provided by Elliot Israel, MD, Brigham and Women's Hospital:
exercise induced asthma
exercise induced bronchoconstriction
long acting beta agonist
exercise challenge
beta 2 adrenergic receptor polymorphisms

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017