Oral Nadolol for the Treatment of Adults With Mild Asthma
Information source: Inverseon, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: nadolol (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Inverseon, Inc.
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: Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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; Recruiting
Benil Mannava, Email: mannava@bcm.tmc.edu
Nick Hanania, M.D., Principal Investigator
Additional Information
Starting date: January 2007
Ending date: December 2008
Last updated: May 5, 2008
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