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Efficacy and Safety of Beta-adrenoceptor Inverse Agonist, Nadolol, in Mild Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01804218
Recruitment Status : Unknown
Verified August 2016 by Invion, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2013
Last Update Posted : August 9, 2016
Information provided by (Responsible Party):
Invion, Inc.

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.

Condition or disease Intervention/treatment Phase
Mild Persistent Asthma, Uncomplicated Drug: Nadolol Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2013
Actual Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Nadolol

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Active, nadolol
Drug: Nadolol

Primary Outcome Measures :
  1. The change in methacholine provocative concentration causing a 20% fall (PC20) based on forced expiratory volume in 1 second (FEV1) between baseline visit and final dose dispensing visit. [ Time Frame: 4 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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 Criteria:

Subjects who meet ANY of the following criteria are not eligible for enrollment:

  1. Inability or unwillingness of the participant to give written informed consent
  2. History of upper/lower respiratory tract infection or asthma exacerbation requiring systemic steroids within 6 weeks of Visit 1
  3. 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.
  4. History of hospitalization for asthma in the preceding year
  5. History of intubation for asthma
  6. Currently diagnosed with chronic obstructive pulmonary disease (COPD)
  7. Currently taking any beta-blocker medication
  8. History of adverse reaction or allergy to any beta-blocker medication
  9. 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
  10. Current diabetes or hyperthyroidism
  11. History of cardiovascular diseases including uncontrolled hypertension (BP >160/100), ischemic heart disease, congestive heart failure, valvular heart disease or cardiomyopathy
  12. Known allergy or sensitivity to atropine or ipratropium bromide
  13. 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
  14. Known bleeding disorders, platelet count <100,000, PT or PTT > 1.5 x normal control (if participating in bronchoscopy sub-study)
  15. Known allergy to lidocaine (if participating in bronchoscopy sub-study)
  16. Documented or self-reported current history of alcoholism or drug abuse
  17. Participation in another research trial within 30 days of starting this trial
  18. Unwillingness or inability to comply with study procedures
  19. Inability to swallow the study medication capsule
  20. Use of any exclusion medication within the time period specified
  21. Pregnant or nursing
  22. Receiving allergen immunotherapy (desensitization injections)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01804218

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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27704
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Invion, Inc.
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Study Chair: Nicola A. Hanania, MD, MS Baylor College of Medicine
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Responsible Party: Invion, Inc. Identifier: NCT01804218    
Other Study ID Numbers: U01-BCM-01
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents