Status:
UNKNOWN
Efficacy and Safety of Beta-adrenoceptor Inverse Agonist, Nadolol, in Mild Asthma
Lead Sponsor:
Invion, Inc.
Conditions:
Mild Persistent Asthma, Uncomplicated
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the hypothesis that 18-22 week treatment with the inverse agonist nadolol will improve airway hyperresponsiveness in patients with mild asthma, compared to placebo...
Eligibility Criteria
Inclusion
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- 1\. Males and females with physician-diagnosed asthma between the ages of 18- 60.
- 2\. Pre-bronchodilator FEV1 80% or greater than the predicted value
- 3\. Baseline PC20 (based on FEV1) ≤ 4 mg/ml on methacholine challenge test.
- 4\. Asthma Control Questionnaire Score (ACQ) \<1.25
- 5\. Baseline blood pressure ≥ 110/65mm Hg
- 6\. Baseline pulse rate ≥ 60 beats/min.
- 7\. Never-smoker or former-smoker \< 10 pack.year and has not smoked within 1 year.
- 8\. Able to complete diary cards and comply with study procedures.
- 9\. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
Exclusion
- Subjects who meet ANY of the following criteria are not eligible for enrollment:
- Inability or unwillingness of the participant to give written informed consent
- History of upper/lower respiratory tract infection or asthma exacerbation requiring systemic steroids within 6 weeks of Visit 1
- Use of rescue medication (e.g., albuterol) more than twice per week during the week preceding Visit 1 excluding the use of such medication as preventative prior to exercise.
- History of hospitalization for asthma in the preceding year
- History of intubation for asthma
- Currently diagnosed with chronic obstructive pulmonary disease (COPD)
- Currently taking any beta-blocker medication
- History of adverse reaction or allergy to any beta-blocker medication
- History of neurological, hepatic, renal, or other medical conditions that may interfere with the interpretation of data or the patient's participation in the study or may increase safety concerns
- Current diabetes or hyperthyroidism
- History of cardiovascular diseases including uncontrolled hypertension (BP \>160/100), ischemic heart disease, congestive heart failure, valvular heart disease or cardiomyopathy
- Known allergy or sensitivity to atropine or ipratropium bromide
- Abnormal entry laboratory values at baseline except for the following tests, where values outside the normal limits will be acceptable as follows: Hct ≥ 30%, platelet count \> 100,000, ALT and AST \< 1.5 x upper normal limit
- Known bleeding disorders, platelet count \<100,000, PT or PTT \> 1.5 x normal control (if participating in bronchoscopy sub-study)
- Known allergy to lidocaine (if participating in bronchoscopy sub-study)
- Documented or self-reported current history of alcoholism or drug abuse
- Participation in another research trial within 30 days of starting this trial
- Unwillingness or inability to comply with study procedures
- Inability to swallow the study medication capsule
- Use of any exclusion medication within the time period specified
- Pregnant or nursing
- Receiving allergen immunotherapy (desensitization injections)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01804218
Start Date
March 1 2013
Last Update
August 9 2016
Active Locations (3)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
Duke University Medical Center
Durham, North Carolina, United States, 27704
3
Baylor College of Medicine
Houston, Texas, United States, 77030