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Oral Nadolol for the Treatment of Adults With Mild Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00670267
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : May 11, 2016
Last Update Posted : May 11, 2016
Sponsor:
Collaborators:
University of Houston
Sandler Program for Asthma Research
Baylor College of Medicine
Information provided by (Responsible Party):
Invion, Inc.

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

Condition or disease Intervention/treatment Phase
Asthma Drug: nadolol Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Nadolol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label treatment with oral Nadolol
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Daily Dose at Study Termination Across Participants [ Time Frame: Baseline to end of study (105 days) ]
    The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.

  2. Daily Dose at Study Termination Across Participants [ Time Frame: Baseline to end of study (105 days) ]
    The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported.


Secondary Outcome Measures :
  1. Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge) [ Time Frame: Baseline to end of study (105 days) ]
    Bronchoprovocation assessment was done by doubling doses of methacholine in accordance with the methodology recommended by the American Thoracic Society in the official policy statement adopted by the ATS Board of Directors, July 1999 (Guidelines for Methacholine and Exercise Challenge Testing-1999).

  2. Percent Change in FEV1% Predicted From Baseline to End of Study [ Time Frame: Baseline to end of study (105 days) ]
  3. Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline [ Time Frame: Baseline to end of study (105 days) ]
    In the E.F. Juniper Asthma Control Questionnaire, a lower number reflects better control of asthma symptoms. A positive change in ACQ score reflects a reduction in control compared to baseline; conversely, a negative change in ACQ score reflects an increase in control compared to baseline. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670267


Locations
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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
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Principal Investigator: Nicola A Hanania, MD University of Houston
More Information
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Additional Information:

Publications:

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Responsible Party: Invion, Inc.
ClinicalTrials.gov Identifier: NCT00670267    
Other Study ID Numbers: SAND1002
First Posted: May 1, 2008    Key Record Dates
Results First Posted: May 11, 2016
Last Update Posted: May 11, 2016
Last Verified: April 2016
Keywords provided by Invion, Inc.:
Asthma
hyperresponsiveness
Additional relevant MeSH terms:
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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
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents