An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma
Overview
- Phase
- Phase 1
- Intervention
- nadolol
- Conditions
- Asthma
- Sponsor
- Invion, Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Mean Daily Dose at Study Termination Across Participants
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Open Label treatment with oral Nadolol
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
Intervention: nadolol
Outcomes
Primary Outcomes
Mean Daily Dose at Study Termination Across Participants
Time Frame: Baseline to end of study (105 days)
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.
Daily Dose at Study Termination Across Participants
Time Frame: Baseline to end of study (105 days)
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.
Secondary Outcomes
- Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)(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(Baseline to end of study (105 days))