Oral Nadolol for the Treatment of Adults With Mild Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670267
• Other study ID #: SAND1002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 29, 2008
• Last updated: February 2, 2010
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: February 2010
• Source: Invion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• nadolol
Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Invion, Inc.	Baylor College of Medicine, Sandler Program for Asthma Research, University of Houston

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety		end of study	Yes
Secondary	Airway hyper-responsiveness		end of study	No