Oral Nadolol for the Treatment of Adults With Mild Asthma

April 6, 2016 updated by: Invion, Inc.

An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Corgard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to end of study (105 days)
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.
Baseline to end of study (105 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline to end of study (105 days)
Percent Change in FEV1% Predicted From Baseline to End of Study
Time Frame: Baseline to end of study (105 days)
Baseline to end of study (105 days)
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).
Baseline to end of study (105 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Invion, Inc.

Collaborators

Baylor College of Medicine
University of Houston
Sandler Program for Asthma Research

Investigators

  • Principal Investigator: Nicola A Hanania, MD, University of Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

May 1, 2008

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAND1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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