We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01825122
First Posted: April 5, 2013
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Invion, Inc.
  Purpose
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.

Condition Intervention Phase
Smoking Cessation Drug: Nadolol Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Invion, Inc.:

Primary Outcome Measures:
  • Change From Baseline in the Average Number of Cigarettes Smoked Per Day [ Time Frame: Baseline to end of treatment, up to 15 weeks ]

Enrollment: 155
Study Start Date: March 2014
Study Completion Date: August 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo
Drug: Placebo
Experimental: Active, nadolol
Active
Drug: Nadolol

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825122


Locations
United States, Arizona
Hope Research Center
Phoenix, Arizona, United States
United States, Florida
Nuren Medical
Miami, Florida, United States, 33144
Abel Buchheim Pharmaceutical Research
Miami, Florida, United States, 33165
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Invion, Inc.
Investigators
Principal Investigator: Mario Castro, M.D. Washington University of St. Louis
  More Information

Responsible Party: Invion, Inc.
ClinicalTrials.gov Identifier: NCT01825122     History of Changes
Other Study ID Numbers: INVSC001
First Submitted: April 2, 2013
First Posted: April 5, 2013
Results First Submitted: September 1, 2016
Results First Posted: October 25, 2016
Last Update Posted: February 1, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
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