Efficacy and Safety of Βeta-adrenoceptor Inverse Agonist and Biased Ligand, Nadolol, In Smoking Cessation of Patients With Chronic Cough With or Without Airflow Obstruction

NCT01825122 | Completed Phase 2 Results

• 1 other identifier: INVSC001
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 4

Brief Summary

To test the hypothesis that treatment with the inverse agonist nadolol will improve smoking cessation in patients with chronic cough associated with long-term smoking, with or without airflow obstruction, including those with established chronic obstructive pulmonary disease (COPD) (chronic bronchitis dominant) or non-obstructive chronic bronchitis (NCB), compared to placebo and standard of care, while undergoing a validated smoking cessation program.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Average Number of Cigarettes Smoked Per Day

  Baseline to end of treatment, up to 15 weeks

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 - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential study participants will be referred from approved smoking cessation programs or be willing to enter a smoking cessation program administered by the participating sites. Individuals who meet all of the following criteria at Visit 1 are eligible for enrollment as study participants:
• Active cigarette-smoking males and females between the ages of 18-70 with chronic cough associated with long-term smoking, with or without airflow obstruction, including Non-obstructive chronic bronchitis (NCB) or physician-diagnosed COPD (chronic bronchitis dominant), as defined by the American Thoracic Society.
• Committed desire to quit smoking in conjunction with participation in an approved smoking cessation program administered by the participating sites. Enrollment in the smoking cessation program must take place prior to Visit 3 (third dose escalation visit).
• Diagnosis of COPD (chronic bronchitis dominant) or NCB, or presenting with chronic cough associated with long-term smoking.
• Pre-bronchodilator FEV1 greater than 55% of predicted
• Baseline blood pressure ≥ 110/65mm Hg
• Baseline heart rate ≥ 60 beats/min.
• Smoking at least 10 cigarettes per day prior to participation in the approved smoking cessation program.
• Self-reported prior failure(s) to quit smoking during participation in a smoking cessation program.
• 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:
• Diagnosis of asthma, cystic fibrosis, or PiZZ emphysema
• Inability or unwillingness to give written informed consent
• History of upper/lower respiratory tract infection, COPD exacerbation requiring systemic steroids, antibiotics, and or ER visit or urgent care within 6 weeks of Visit 1
• History of adverse reaction or allergy to nadolol
• 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
• History of cardiovascular diseases including uncontrolled hypertension (BP \>160/100), ischemic heart disease, congestive heart failure (NYHA III or IV), valvular heart disease or cardiomyopathy
• Known allergy or sensitivity to atropine or ipratropium bromide
• 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
• Pregnant or nursing
• Current use of any OTC remedies containing pseudoephedrine, ephedrine-based or containing dietary or herbal supplements.
• Scheduled for surgery requiring general anaesthesia

Sponsors & Collaborators

• Invion, Inc.: lead

Study Sites (4)

Hope Research Center

Phoenix, Arizona, United States

Location

Nuren Medical

Miami, Florida, 33144, United States

Location

Abel Buchheim Pharmaceutical Research

Miami, Florida, 33165, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nadolol

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mitchell Glass, M.D., EVP of R&D
• Organization: Invion, Inc.

mitchell.glass@inviongroup.com

+61 7 3295 0500

Study Officials

• Mario Castro, M.D.

  Washington University of St. Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 5, 2013
• Study Start: March 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 1, 2017
• Results First Posted: October 25, 2016

Record last verified: 2016-12

Locations

US (4)