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

Smoking Cessation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825122
• Other study ID #: INVSC001
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2013
• Last updated: August 17, 2015
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Invion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To test the hypothesis that 11-15 week 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nadolol

• Placebo

Locations

Country	Name	City	State
United States	Abel Buchheim Pharmaceutical Research	Miami	Florida
United States	Nuren Medical	Miami	Florida
United States	Hope Research Center	Phoenix	Arizona
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Invion, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the average number of cigarettes smoked per day in a week		Last 28 days on study medication	No