Oral Nadolol for the Treatment of Adults With Mild Asthma

Study Overview
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Brief Summary
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The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.

Official Title
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An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: nadolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-bronchodilator FEV1 80% or greater than the predicted value. PC20 FEV1 ≤4 mg/ml on methacholine challenge test. Blood Pressure ≥ 100/65mm Hg. Pulse rate ≥ 60 beats/min. No significant health issues. Non-smoker or X-smoker < 10 pack/year. Exclusion Criteria: History of upper/lower respiratory tract infection or asthma exacerbation within 6 weeks of first baseline visit. Currently diagnosed with chronic obstructive pulmonary disease (COPD). Used any oral or inhaled corticosteroids within 4 weeks of the first baseline visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label treatment with oral Nadolol<br>Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated. | Drug: nadolol<br>* Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.<br>* Other names: Corgard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Daily Dose at Study Termination Across Participants | The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out. | Baseline to end of study (105 days) | 
| Daily Dose at Study Termination Across Participants | The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported. | Baseline to end of study (105 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge) | Bronchoprovocation assessment was done by doubling doses of methacholine in accordance with the methodology recommended by the American Thoracic Society in the official policy statement adopted by the ATS Board of Directors, July 1999 (Guidelines for Methacholine and Exercise Challenge Testing-1999). | Baseline to end of study (105 days) | 
| Percent Change in FEV1% Predicted From Baseline to End of Study |  | Baseline to end of study (105 days) | 
| Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline | In the E.F. Juniper Asthma Control Questionnaire, a lower number reflects better control of asthma symptoms. A positive change in ACQ score reflects a reduction in control compared to baseline; conversely, a negative change in ACQ score reflects an increase in control compared to baseline. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). | Baseline to end of study (105 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, hyperresponsiveness