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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo |
|
| Active, nadolol | Experimental | Active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadolol | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Average Number of Cigarettes Smoked Per Day | Baseline to end of treatment, up to 15 weeks |
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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:
Exclusion Criteria:
Subjects who meet ANY of the following criteria are not eligible for enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Castro, M.D. | Washington University of St. Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Center | Phoenix | Arizona | United States | |||
| Nuren Medical |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo Placebo |
| FG001 | Active, Nadolol | Active Nadolol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Miami |
| Florida |
| 33144 |
| United States |
| Abel Buchheim Pharmaceutical Research | Miami | Florida | 33165 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo Placebo |
| BG001 | Active, Nadolol | Active Nadolol |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Average Number of Cigarettes Smoked Per Day | The analysis population reflects all patients who achieved maintenance dosing, including those who did not complete the study | Posted | Number | participants | Baseline to end of treatment, up to 15 weeks |
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Up to 30 days following discontinuation of the study, for up to 21 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo Placebo | 1 | 77 | 34 | 77 | ||
| EG001 | Active, Nadolol | Active Nadolol | 2 | 78 | 35 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) |
| ||
| Bipolar episode | Psychiatric disorders | MedDRA (Unspecified) |
| ||
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Cardiac disorders | MedDRA (Unspecified) |
| ||
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) |
| ||
| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) |
| ||
| Dysgeusia | Gastrointestinal disorders | MedDRA (Unspecified) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) |
| ||
| Headache | Nervous system disorders | MedDRA (Unspecified) |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Glass, M.D., EVP of R&D | Invion, Inc. | +61 7 3295 0500 | mitchell.glass@inviongroup.com |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009248 | Nadolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
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| >=65 years |
|
| Male |
|