Smoking CessationPhase 2NCT01825122
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
A Phase 2 study testing Nadolol in people with Smoking Cessation, run by Invion, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nadolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2014to Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
- Referred for smoking cessation without serious commitment to quit
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Nuren Medical
Miami, Florida, 33144
Abel Buchheim Pharmaceutical Research
Miami, Florida, 33165
Hope Research Center
Phoenix, Arizona
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Nadolol, Placebo
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NadololDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
| Active, nadolol | Experimental | Active Receives: Drug: Nadolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Average Number of Cigarettes Smoked Per Day
Measured: Baseline to end of treatment, up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Castro, M.D., Principal investigator, Washington University of St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825122
- Sponsor's protocol ID
- INVSC001
- Status last verified
- Dec 2016
- First submitted
- 2 Apr 2013
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01825122
- Acronym / sponsor ID
- INVSC001
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Invion, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Posted 25 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo |
| Active, nadolol | Experimental | Drug: NadololActive |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nadolol | Drug | Active, nadolol |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in the Average Number of Cigarettes Smoked Per Day
Time frame: Baseline to end of treatment, up to 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Castro, M.D. principal investigator
Washington University of St. Louis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nadolol in people with Smoking Cessation, run by Invion, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Average Number of Cigarettes Smoked Per Day (time frame: Baseline to end of treatment, up to 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.