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The purpose of this study is to test the hypothesis that 18-22 week treatment with the inverse agonist nadolol will improve airway hyperresponsiveness in patients with mild asthma, compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Active, nadolol | Experimental | Active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadolol | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The change in methacholine provocative concentration causing a 20% fall (PC20) based on forced expiratory volume in 1 second (FEV1) between baseline visit and final dose dispensing visit. | 4 months |
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Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
1. Males and females with physician-diagnosed asthma between the ages of 18- 60.
2. Pre-bronchodilator FEV1 80% or greater than the predicted value
3. Baseline PC20 (based on FEV1) ≤ 4 mg/ml on methacholine challenge test.
4. Asthma Control Questionnaire Score (ACQ) <1.25
5. Baseline blood pressure ≥ 110/65mm Hg
6. Baseline pulse rate ≥ 60 beats/min.
7. Never-smoker or former-smoker < 10 pack.year and has not smoked within 1 year.
8. Able to complete diary cards and comply with study procedures.
9. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
Exclusion Criteria:
Subjects who meet ANY of the following criteria are not eligible for enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola A. Hanania, MD, MS | Baylor College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States | ||
| Duke University Medical Center |
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| ID | Term |
|---|---|
| D009248 | Nadolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
| Durham |
| North Carolina |
| 27704 |
| United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |