Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 (Responsible Party):
Invion, Inc.
ClinicalTrials.gov Identifier:
NCT00670267
First received: April 29, 2008
Last updated: April 6, 2016
Last verified: April 2016
  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:
  • Mean Daily Dose at Study Termination Across Participants [ Time Frame: Baseline to end of study (105 days) ] [ Designated as safety issue: Yes ]
    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.

  • Daily Dose at Study Termination Across Participants [ Time Frame: Baseline to end of study (105 days) ] [ Designated as safety issue: Yes ]
    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:
  • 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) ] [ Designated as safety issue: Yes ]
    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).

  • Percent Change in FEV1% Predicted From Baseline to End of Study [ Time Frame: Baseline to end of study (105 days) ] [ Designated as safety issue: Yes ]
  • Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline [ Time Frame: Baseline to end of study (105 days) ] [ Designated as safety issue: Yes ]
    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).


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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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: Nicola A Hanania, MD University of Houston
  More Information

Additional Information:
Publications:
Responsible Party: Invion, Inc.
ClinicalTrials.gov Identifier: NCT00670267     History of Changes
Other Study ID Numbers: SAND1002 
Study First Received: April 29, 2008
Results First Received: June 16, 2015
Last Updated: April 6, 2016
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
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on December 02, 2016