Oral Nadolol for the Treatment of Adults With Mild Asthma

This study has been completed.

First Received on April 29, 2008. Last Updated on February 2, 2010 History of Changes

Sponsor:	Inverseon, Inc.
Collaborators:	University of Houston Sandler Program for Asthma Research Baylor College of Medicine
Information provided by:	Inverseon, Inc.
ClinicalTrials.gov Identifier:	NCT00670267

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: nadolol	Phase I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Nadolol

U.S. FDA Resources

Further study details as provided by Inverseon, Inc.:

Primary Outcome Measures:

safety [ Time Frame: end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Airway hyper-responsiveness [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	January 2007
Study Completion Date:	June 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: Corgard

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670267

Locations

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Inverseon, Inc.

University of Houston

Sandler Program for Asthma Research

Baylor College of Medicine

Investigators

Principal Investigator:

Richard A Bond, PhD

University of Houston

More Information

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. Epub 2009 Jan 26.

Responsible Party:	Professor Nick Hanania, M.D., The Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00670267 History of Changes
Other Study ID Numbers:	SAND1002
Study First Received:	April 29, 2008
Last Updated:	February 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inverseon, Inc.:

Asthma
hyperresponsiveness

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nadolol
Adrenergic beta-Antagonists
Adrenergic Antagonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012