Oral Nadolol for the Treatment of Adults With Mild Asthma
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|ClinicalTrials.gov Identifier: NCT00670267|
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : May 11, 2016
Last Update Posted : May 11, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: nadolol||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
Other Name: Corgard
- 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.
- 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.
- 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).
- Percent Change in FEV1% Predicted From Baseline to End of Study [ Time Frame: 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).
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nicola A Hanania, MD||University of Houston|
|Responsible Party:||Invion, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 1, 2008 Key Record Dates|
|Results First Posted:||May 11, 2016|
|Last Update Posted:||May 11, 2016|
|Last Verified:||April 2016|
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Peripheral Nervous System Agents