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

NCT01804218 | Unknown Phase 2 DMC

• 1 other identifier: U01-BCM-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Mild Persistent Asthma, Uncomplicated

Outcome Measures

Primary Outcomes (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.

  4 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Active, nadolol

EXPERIMENTAL

Active

Drug: Nadolol

Interventions

Nadolol DRUG

Active, nadolol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who meet all of the following criteria are eligible for enrollment as study participants:
• \. Males and females with physician-diagnosed asthma between the ages of 18- 60.
• \. Pre-bronchodilator FEV1 80% or greater than the predicted value
• \. Baseline PC20 (based on FEV1) ≤ 4 mg/ml on methacholine challenge test.
• \. Asthma Control Questionnaire Score (ACQ) \<1.25
• \. Baseline blood pressure ≥ 110/65mm Hg
• \. Baseline pulse rate ≥ 60 beats/min.
• \. Never-smoker or former-smoker \< 10 pack.year and has not smoked within 1 year.
• \. Able to complete diary cards and comply with study procedures.
• \. 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Invion, Inc.: lead

Study Sites (3)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center

Durham, North Carolina, 27704, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Nadolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Nicola A. Hanania, MD, MS

  Baylor College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 5, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (3)