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Completed

NCT Number: NCT00670267

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.

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nadolol

Drug

Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.

Other names: Corgard

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Invion, Inc.

Industry

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 1, 2008
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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