Oral Nadolol for the Treatment of Adults With Mild Asthma
Information source: Invion, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: nadolol (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Invion, Inc. Official(s) and/or principal investigator(s): Richard A Bond, PhD, Principal Investigator, Affiliation: University of Houston
Summary
The purpose of this study is to confirm previous observations in asthmatics that chronic
nadolol treatment reduces asthmatic airway hyper-responsiveness.
Clinical Details
Official title: An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: safety
Secondary outcome: Airway hyper-responsiveness
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Baylor College of Medicine, Houston, Texas 77030, United States
Additional Information
Related publications: Hanania NA, Singh S, El-Wali R, Flashner M, Franklin AE, Garner WJ, Dickey BF, Parra S, Ruoss S, Shardonofsky F, O'Connor BJ, Page C, Bond RA. The safety and effects of the beta-blocker, nadolol, in mild asthma: an open-label pilot study. Pulm Pharmacol Ther. 2008;21(1):134-41. Epub 2007 Jul 17. Nguyen LP, Lin R, Parra S, Omoluabi O, Hanania NA, Tuvim MJ, Knoll BJ, Dickey BF, Bond RA. Beta2-adrenoceptor signaling is required for the development of an asthma phenotype in a murine model. Proc Natl Acad Sci U S A. 2009 Feb 17;106(7):2435-40. doi: 10.1073/pnas.0810902106. Epub 2009 Jan 26.
Starting date: January 2007
Last updated: February 2, 2010
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