Title
Oral Nadolol for the Treatment of Adults With Mild Asthma
An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma
Phase
Phase 1/Phase 2Lead Sponsor
Invion, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
AsthmaIntervention/Treatment
nadolol ...Study Participants
10The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
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.
| Event Type | Organ System | Event Term | Open Label |
|---|
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.
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.
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).
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).
