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Trial record 2 of 2 for:    nadolol asthma

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Invion, Inc.
ClinicalTrials.gov Identifier:
NCT01804218
First received: March 1, 2013
Last updated: August 5, 2016
Last verified: August 2016
  Purpose
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 Intervention Phase
Mild Persistent Asthma, Uncomplicated Drug: Nadolol Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Invion, Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: March 2013
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Experimental: Active, nadolol
Active
Drug: Nadolol

  Eligibility

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

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804218

Locations
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.
Investigators
Study Chair: Nicola A. Hanania, MD, MS Baylor College of Medicine
  More Information

Responsible Party: Invion, Inc.
ClinicalTrials.gov Identifier: NCT01804218     History of Changes
Other Study ID Numbers: U01-BCM-01
Study First Received: March 1, 2013
Last Updated: August 5, 2016

Additional relevant MeSH terms:
Asthma
Nadolol
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
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
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 21, 2017