Oral Nadolol for the Treatment of Adults With Mild Asthma

This study is currently recruiting participants.

Verified by Inverseon, Inc., April 2008

First Received: April 29, 2008 Last Updated: May 5, 2008 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:	Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	10
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (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.

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	Recruiting
Houston, Texas, United States, 77030
Contact: Benil Mannava mannava@bcm.tmc.edu
Principal Investigator: Nick Hanania, M.D.

Sponsors and Collaborators

Inverseon, Inc.

University of Houston

Sandler Program for Asthma Research

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	The Baylor College of Medicine ( Professor Nick Hanania, M.D. )
Study ID Numbers:	SAND1002
Study First Received:	April 29, 2008
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00670267 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inverseon, Inc.:

Asthma
hyperresponsiveness

Additional relevant MeSH terms:

Sympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Immune System Diseases
Adrenergic Agents
Physiological Effects of Drugs
Asthma
Nadolol
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 22, 2009