An interventional study of salmeterol in Asthma, sponsored by Brigham and Women's Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-06-08.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 30 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arg/Arg subjects on 2 week salmeterol treatment
Drug: salmeterol
Gly/Gly subjects on 2 week salmeterol treatment
Drug: salmeterol
salmeterol 50 micrograms twice daily for 2 weeks
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 after exercise challenge
Comparison of the Maximum Percent Fall in FEV1 From Pre-salmeterol Baseline to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients
Time frame: 2 weeks from pre-salmeterol baseline
Comparison of the Maximum Percent Fall in FEV1 After 1st Dose of Salmeterol to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects
Time frame: 2 weeks after 1st dose of Salmeterol
| Milestone | Arg/Arg | Gly/Gly |
|---|---|---|
| Started | 12 | 18 |
| Completed | 12 | 18 |
| Not completed | 0 | 0 |
| % fall FEV1 | Arg/Arg | Gly/Gly |
|---|---|---|
| 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 | 12.6 ± 4.5 | 16.5 ± 2.9 |
| % fall FEV1 | Arg/Arg | Gly/Gly |
|---|---|---|
| Comparison of the Maximum Percent Fall in FEV1 From Pre-salmeterol Baseline to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients | 5.9 ± 19.9 | 4.3 ± 10.6 |
| % fall FEV1 | Arg/Arg | Gly/Gly |
|---|---|---|
| Comparison of the Maximum Percent Fall in FEV1 After 1st Dose of Salmeterol to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects | -12.6 ± 17.1 | -16.5 ± 10.9 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arg/Arg | — | 0/12 (0%) | 0/12 (0%) |
| Gly/Gly | — | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Arg/Arg | Gly/Gly | Total |
|---|---|---|---|
| Mean | 25.8 ± 2.4 | 27.2 ± 1.4 | 26.6 ± 1.3 |
| Age, Categorical(Participants) | Arg/Arg | Gly/Gly | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 14 | 26 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Arg/Arg | Gly/Gly | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 2 | 4 | 6 |
| Region of Enrollment(participants) | Arg/Arg | Gly/Gly | Total |
|---|---|---|---|
| United States | 12 | 14 | 26 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brigham and Women's Hospital