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Oral Nadolol for the Treatment of Adults With Mild Asthma

This study has been completed.
University of Houston
Sandler Program for Asthma Research
Baylor College of Medicine
Information provided by:
Invion, Inc. Identifier:
First received: April 29, 2008
Last updated: February 2, 2010
Last verified: February 2010

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

Condition Intervention Phase
Drug: nadolol
Phase 1
Phase 2

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:

Further study details as provided by Invion, 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:
    Drug: nadolol
    Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
    Other Name: Corgard

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

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.
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Please refer to this study by its identifier: NCT00670267

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Invion, Inc.
University of Houston
Sandler Program for Asthma Research
Baylor College of Medicine
Principal Investigator: Richard A Bond, PhD University of Houston
  More Information

Responsible Party: Professor Nick Hanania, M.D., The Baylor College of Medicine 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 Invion, Inc.:

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 20, 2014