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

• ClinicalTrials.gov Identifier: NCT01804218
• Recruitment Status: Unknown
• First Posted: March 5, 2013
• Last Update Posted: August 9, 2016
• Sponsor: Invion, Inc.
• Information provided by (Responsible Party): Invion, Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

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
• Other Study ID Numbers: U01-BCM-01
• First Posted: March 5, 2013
• Last Update Posted: August 9, 2016
• Last Verified: August 2016

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nadolol; 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