Clinical trial NCT01825122: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: Invion, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-05
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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:

1. 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.
2. 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).
3. Diagnosis of COPD (chronic bronchitis dominant) or NCB, or presenting with chronic cough associated with long-term smoking.
4. Pre-bronchodilator FEV1 greater than 55% of predicted
5. Baseline blood pressure ≥ 110/65mm Hg
6. Baseline heart rate ≥ 60 beats/min.
7. Smoking at least 10 cigarettes per day prior to participation in the approved smoking cessation program.
8. Self-reported prior failure(s) to quit smoking during participation in a smoking cessation program.
9. Able to complete diary cards and comply with study procedures.
10. 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. Diagnosis of asthma, cystic fibrosis, or PiZZ emphysema
2. Inability or unwillingness to give written informed consent
3. 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
4. History of adverse reaction or allergy to nadolol
5. 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
6. 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
7. Known allergy or sensitivity to atropine or ipratropium bromide
8. Documented or self-reported current history of alcoholism or drug abuse
9. Participation in another research trial within 30 days of starting this trial
10. Unwillingness or inability to comply with study procedures
11. Inability to swallow the study medication
12. Pregnant or nursing
13. Current use of any OTC remedies containing pseudoephedrine, ephedrine-based or containing dietary or herbal supplements.
14. Scheduled for surgery requiring general anaesthesia
15. Referred for smoking cessation without serious commitment to quit

Primary outcomes:
measure: Change From Baseline in the Average Number of Cigarettes Smoked Per Day
timeFrame: Baseline to end of treatment, up to 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Center
state: Arizona
city: Miami
country: United States
facility: Nuren Medical
state: Florida
city: Miami
country: United States
facility: Abel Buchheim Pharmaceutical Research
state: Florida
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University of St. Louis
name: Mario Castro, M.D.
role: PRINCIPAL_INVESTIGATOR
References: