Phase 2
N=10
Oral Nadolol for the Treatment of Adults With Mild Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00670267 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Mean Daily Dose at Study Termination Across Participants — 29.6 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- nadolol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Invion, Inc.
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Dose at Study Termination Across Participants |
29.6 | — |
| PRIMARY Daily Dose at Study Termination Across Participants |
1; 0; 1; 1; 0; 7 | — |
| SECONDARY Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge) |
1.8 | — |
| SECONDARY Percent Change in FEV1% Predicted From Baseline to End of Study |
-5.9 | — |
| SECONDARY Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline |
0.3 | — |
Summary
The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
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.
Data sourced from ClinicalTrials.gov (NCT00670267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.