Hypothesis: The endothelin-1 receptor antagonist, bosentan when added to the treatment of asthma patients who are symptomatic despite the use of controller therapy will improve asthma symptoms and physiology. Twenty patients with a diagnosis of asthma, between the ages of 21 and 70 who are symptomatic despite the use of at least one controller medication will be randomized to either placebo or active medication for an 8 week period (initial 4 weeks is at 1/2 of final dose as per package insert and FDA approval). Measures of lung function and symptoms will be recorded. Patients will then cross over, so that patients initially on placebo will receive active drug for 8 weeks and those initially on active drug will receive placebo. The same endpoints will be measured. The acute bronchodilator effects of the drug will also be tested on the first day of therapy at the full therapeutic dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
11
Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
University of Connecticut Health Center
Farmington, Connecticut, United States
Change in FEV1
Time frame: 1, 2, 4 hours after dosing
Peak Flow
Time frame: last 7 days of each dosing period
Symptom Scores
Symptom score could range from a minimum of 7 (no symptoms) to 35 (severe symptoms)
Time frame: Last 7 days of each dosing period
FEV1
Time frame: end of dosing period
Rescue Beta-agonist
Time frame: end of each dosing period
Asthma Control Test Questionnaire
Patient reported outcome minimum 5 (no symptoms) maximum 25 (severe symptoms)
Time frame: end of each dosing period
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