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Smoking CessationPhase 3NCT00285012

Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).

A Phase 3 study testing Varenicline Tartarate in people with Smoking Cessation, run by Pfizer at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
Varenicline Tartarate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
504 participants
Where
32 sitesin 4 countries
Study dates
May 2006to Apr 2009
Phase
Phase 3
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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be current cigarette smokers who have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit.
  • mild to moderate COPD confirmed by spirometry
  • Subjects must have a clinical diagnosis of COPD.

Who cannot join

  • Subjects who have made a serious attempt to quit smoking in the past 3 months.
  • Subjects who have been previously randomized in a study that has included varenicline.

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

United States22 sites

  • Pfizer Investigational Site

    Birmingham, Alabama, 35249-2181

  • Pfizer Investigational Site

    Chapel Hill, North Carolina, 27517

  • Pfizer Investigational Site

    Chapel Hill, North Carolina, 27599-7020

  • Pfizer Investigational Site

    Denver, Colorado, 80206

  • Pfizer Investigational Site

    Farmington, Connecticut, 06030-2810

  • Pfizer Investigational Site

    Farmington, Connecticut, 06030

  • Pfizer Investigational Site

    Houston, Texas, 77030-1608

  • Pfizer Investigational Site

    Lexington, Kentucky, 40509

  • Pfizer Investigational Site

    Los Angeles, California, 90095-1690

  • Pfizer Investigational Site

    Los Angeles, California, 90095-6984

  • Pfizer Investigational Site

    Miami, Florida, 33143

  • Pfizer Investigational Site

    Nashville, Tennessee, 37203

  • Pfizer Investigational Site

    North Dartmouth, Massachusetts, 02747

  • Pfizer Investigational Site

    Omaha, Nebraska, 68198-5885

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Pfizer Investigational Site

    Portland, Maine, 04102

  • Pfizer Investigational Site

    Portland, Oregon, 97239-3098

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27607

  • Pfizer Investigational Site

    Rochester, Minnesota, 55905

  • Pfizer Investigational Site

    Rochester, New York, 14609

  • Pfizer Investigational Site

    Winston-Salem, North Carolina, 27103

  • Pfizer Investigational Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

France4 sites

  • Pfizer Investigational Site

    Brest, 29609

  • Pfizer Investigational Site

    Montpellier, 34295

  • Pfizer Investigational Site

    Nice, 06000

  • Pfizer Investigational Site

    Paris, 75679

Other trials in France

Italy3 sites

  • Pfizer Investigational Site

    Modena, 41100

  • Pfizer Investigational Site

    Pisa, 56124

  • Pfizer Investigational Site

    Vittorio Veneto, TV, 31029

Other trials in Italy

Spain3 sites

  • Pfizer Investigational Site

    Cáceres, Caceres, 10003

  • Pfizer Investigational Site

    L'hospitalet Del Llobregat, Barcelona, 08907

  • Pfizer Investigational Site

    Madrid, Madrid, 28015

Other trials in Spain

About this study

Official title: 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

This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.

Being tested
placebo, Varenicline Tartarate
Keywords
smoking cessation, smoking cessation in COPD
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)

  • Varenicline TartarateDrug

    Also called Chantix, Champix

    1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)

Study groups in NCT00285012
Study groupRoleWhat they receive
placeboPlacebo comparatorNot described
Receives: Drug: placebo
vareniclineExperimentalNot described
Receives: Drug: Varenicline Tartarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Four Week Continuous Quit Rate (CQR)

    Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory [NUI]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).

    Measured: Week 9 through Week 12

Secondary outcomes (9)

  1. Number of Subjects With Continuous Abstinence (CA)

    Number of subjects who reported no smoking and no use of other nicotine-containing products (treatment phase = through week 12) or tobacco products (non-treatment phase = after treatment phase; follow up through week 52) at each contact (on the NUI) and with end-expiratory exhaled CO measurement less than or equal to 10 ppm from week 9 through week 24 and week 52. CO confirmed in-clinic visit.

    Measured: Week 9 through Week 24 and Week 52

  2. Number of Subjects With Long Term Quit Rate (LTQR)

    Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of smoking from Week 12 through the given visit (Week 24 and Week 52).

    CO confirmed in-clinic visit.

    Measured: Week 24, Week 52

  3. Number of Subjects With 7-Day Point Prevalence of Abstinence

    Number of subjects at given visit (Week 12, Week 24, Week 52) or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and with end-expiratory exhaled CO measurement less than or equal to 10 ppm. CO confirmed in-clinic visit.

    Measured: Week 12, Week 24, Week 52

  4. Number of Subjects With 4-Week Point Prevalence of Abstinence

    Number of subjects at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks and with end-expiratory exhaled CO measurement less than or equal to 10 ppm.

    Measured: Week 52

  5. Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)

    Change from baseline in mean FEV1 (forced expiratory volume in the first second of forced exhalation) measured in millimeters (ml) as mean at observation minus baseline value. Directly after pre-bronchodilator measurement, subject inhaled albuterol or salbutamol delivered by metered-dose inhaler (MDI); post-bronchodilator lung function repeated 30 to 45 minutes following administration of albuterol or salbutamol.

    Measured: Baseline, Week 12, Week 52

  6. Change From Baseline in Clinical COPD Questionnaire (CCQ)

    Change from baseline: mean at observation minus baseline value. Subject-administered 10-item instrument to systematically assess COPD symptoms (items 1, 2, 5, and 6), functional states (items 7, 8, 9, and 10) and mental states (items 3 and 4); For each domain score = sum of items divided by the number of items; total score = sum of scores divided by 10; range from 0 (very good health) to 6 (extremely poor health). Assessed at each visit based on subject's experience during the week prior to visit.

    Measured: Baseline, Week, 12, Week 24, Week 52

  7. Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period

    Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries.

    Measured: Day 1 through Day 21

  8. Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen

    Change from baseline in CRP and Fibrinogen antigen (blood markers of inflammation) calculated as mean at observation minus baseline value; measured as milligrams per deciliter (mg/dl).

    Measured: Baseline, Week 12, Week 52

  9. Change From Baseline in Body Weight

    Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg).

    Measured: Baseline, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2008
  4. Study completionApr 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00285012
Sponsor's protocol ID
A3051054
Status last verified
Apr 2010
First submitted
30 Jan 2006
Last updated
20 Apr 2010
Data monitoring committee
No

Publications

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PubMed 37142273

  • Tashkin DP, Rennard S, Taylor Hays J, Lawrence D, Marton JP, Lee TC. Lung function and respiratory symptoms in a 1-year randomized smoking cessation trial of varenicline in COPD patients. Respir Med. 2011 Nov;105(11):1682-90. doi: 10.1016/j.rmed.2011.04.016. Epub 2011 May 31.

    PubMed 21621992

  • Tashkin DP, Rennard S, Hays JT, Ma W, Lawrence D, Lee TC. Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial. Chest. 2011 Mar;139(3):591-599. doi: 10.1378/chest.10-0865. Epub 2010 Sep 23.

    PubMed 20864613

  • Ryerson CJ, Berkeley J, Carrieri-Kohlman VL, Pantilat SZ, Landefeld CS, Collard HR. Depression and functional status are strongly associated with dyspnea in interstitial lung disease. Chest. 2011 Mar;139(3):609-616. doi: 10.1378/chest.10-0608. Epub 2010 Aug 5.

    PubMed 20688924

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Varenicline Tartarate in people with Smoking Cessation, run by Pfizer at 32 sites in 4 countries.

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 3 inclusion and 2 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 20 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, France, Italy, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 3 Dec 2009). 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?

Number of Subjects With Four Week Continuous Quit Rate (CQR) (time frame: Week 9 through Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00285012, which also lists 4 linked publications.

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 20 Apr 2010.

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