Oral Nadolol for the Treatment of Adults With Mild Asthma

This study has been completed.
Sponsor:
Collaborators:
University of Houston
Sandler Program for Asthma Research
Baylor College of Medicine
Information provided by:
Invion, Inc.
ClinicalTrials.gov Identifier:
NCT00670267
First received: April 29, 2008
Last updated: February 2, 2010
Last verified: February 2010
  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 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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Invion, 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:
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 Invion, 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 September 18, 2014