A 12-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL WITH 40-WEEK FOLLOW-UP EVALUATING THE SAFETY AND EFFICACY OF VARENICLINE TARTRATE FOR SMOKING CESSATION IN PATIENTS WITH MILD-TO-MODERATE CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Active, not recruiting

• Conditions: Smoking Cessation; MedDRA version: 14.1Level: PTClassification code 10053325Term: Smoking cessation therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2005-004412-70-IT
• Lead Sponsor: PFIZER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-07
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Subjects will be current cigarette smokers 35 years of age and older who have mild to moderate COPD (as defined by the 2003 GOLD criteria), and who are motivated to stop smoking. 2. Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no period of abstinence(cumulative) greater than three months in the past year 3. Subjects must have a clinical diagnosis of COPD at Screening (i.e., confirmed with a postbronchodilator FEV1/FVC < 70%). Additionally the subject must have at Screening an FEV1 >/= 50% of predicted normal value after the administration of a short-acting bronchodilator (albuterol or salbutamol 400 mcg). 4. Females who are not of childbearing potential (i.e., who are surgically sterilized or at least 2 years postmenopausal) and who are not nursing may be included. Females who are of childbearing potential may be included provided that they are not pregnant, not nursing, and meet all of the following criteria: ? Are instructed and agree to avoid pregnancy through 30 days after the last dose of study medication . Have a negative serum pregnancy test (β-hCH) at screening ? Agree to use at least one of the birth control methods listed below: - An oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least 1 month prior to entering the study and will continue its use through at least 30 days after the last dose of study medication; or - A barrier method of contraception, e.g., condom and/or diaphragm with spermicide while participating in the study through at least 30 days after the last dose of study medication; or - Abstinence 5. Subjects must be able to be outpatients and be assessed in a clinic setting, and be able and willing to comply with all study visits during the treatment and nontreatment periods 6. Participating subjects must be able to provide written informed consent 7. Only 1 patient per household may participate in the trial
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects who have made a serious attempt to quit smoking in the past 3 months 2.Subjects taking another investigational drug within 30 days or 5 half-lives (whichever is longer) of study enrollment or plans to take another investigational drug within 30 days of study completion 3.Subjects who have been previously randomized in a study that has included varenicline 4.Subjects currently receiving treatment or who have received treatment within the past 12 months for depression 5.Subjects with a past or present history of panic disorder, psychosis, or bipolar disorder 6.Subjects intending to donate blood or blood components while receiving experimental drug or within 1 month of the completion of the study 7.Subjects requiring other medications during the study that might interfere with the evaluation of the study drug (eg, nicotine replacement therapy, bupropion, clonidine, nortriptyline, or other medications used for smoking cessation including over-the-counter or herbal remedies) 8.Subjects with clinically significant abnormal electrocardiograms atscreening or baseline, unstable cardiovascular disease or history or cardiovascular events in the past 6 months, such as coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty(PTCA), severe or unstable angina, serious arrhythmia, and clinically significant cardiac conduction abnormalities 9.Subjects with uncontrolled hypertension or a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 95 mm Hg at screening or baseline 10.Subjects with clinically significant neurological disorders or cerebrovascular events (eg, stroke, transient ischemic attack, etc.) in the past 6 months 11.Subjects with a history of clinically significant endocrine disorders or gastrointestinal diseases, including diabetes mellitus with HbA1c >/=9, uncontrolled hyperthyroidism, and active peptic ulcer disease 12.Subjects with any condition possibly affecting drug absorption 13.Subjects with clinically significant hepatic or renal impairment or other clinically significant abnormal laboratory test values ? Subjects with moderately severe or severe abnormalities of renal function (estimatedcreatinine clearance by Cockcroft-Gault equation < 50 ml/min, see Appendix 3) ? Subjects with SGOT (AST) or SGPT (ALT) greater than 1.5 times the upper limit of normal (ULN) or total bilirubin greater than 1.1 times the ULN 14.Subjects with an active malignanacy of any type, or a history of malignancy (Subjects who have a history of basal cell carcinoma that has been successfully treated are allowed. Subjects with a history of other malignancies which have been surgically removed and who have had no evidence of other recurrence for at least 5 years before enrollment in the study are also allowed.) 15.Subjects with evidence of or history of clinically significant allergic reactions to drugs (eg, severe cutaneous and /or systemic allergic reactions) 16.Subjects with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months 17.Subjects who have used a nicotine replacement product, buproprion, clonidine, nortriptyline within the previous 3 months, or have participated in a study with an experimental or marketed drug for smoking cessation within the past one year 18.Subjects who do not agree to abstain completely from using non-cigarette tobacco products(including pipe tobacco, cigars, snuff, chewing tobacco, etc.) or m

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary efficacy objective is a comparison of 12 weeks of treatment with varenicline 1 mg BID with placebo for smoking cessation efficacy in subjects with mild to moderate COPD, and to evaluate continuous abstinence for 40 weeks after the treatment period.;Secondary Objective: The safety objective is to gather safety data in subjects with COPD for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 40 weeks of nontreatment follow-up.;Primary end point(s): The primary efficacy endpoint is the 4-week continuous quit rate (CQR) for Weeks 9-12, i.e., the proportion of subjects who are able to maintain complete abstinence from cigarette smoking and other nicotine use, with end-expiratory exhaled CO measurements ≤ 10 ppm, for the planned last 4 weeks of treatment.