title: Lung function and respiratory symptoms in a 1-year randomized smoking cessation trial of varenicline in COPD patients.
abstract: There are few data concerning changes in lung function and respiratory symptoms in smokers with chronic obstructive pulmonary disease (COPD) weeks to months after quitting smoking. We examined serial changes in spirometry and Clinical COPD Questionnaire (CCQ) scores (measuring respiratory symptoms and health-related quality of life) in COPD participants by smoking status during a smoking cessation trial. In this randomized, double-blind trial, smokers with mild-to-moderate COPD were treated with varenicline 1 mg b.i.d. or placebo for 12 weeks and followed to Week 52. Primary endpoints of abstinence were previously reported. Secondary endpoints were mean changes from baseline in post-bronchodilator forced expired volume in 1 s (FEV(1)) and CCQ scores. Change from baseline in post-bronchodilator FEV(1) was significantly improved in continuous abstainers (121.8 mL) vs. continuous smokers (37.9 mL) at Week 12 (P = 0.0069), but not at Weeks 24 or 52. Mean change from baseline at Week 12 in CCQ Total Score was significantly better in continuous abstainers (-1.04) vs. continuous smokers (-0.53; P < 0.0001): this improvement was sustained at Weeks 24 and 52. In a 1-year cessation trial of smokers with COPD, continuous abstinence compared with continuous smoking significantly improved post-bronchodilator FEV(1) at Week 12 (although the difference narrowed subsequently) and CCQ Total Scores at Week 12, with sustained improvement thereafter. (
  
  
  BACKGROUND
  http://www.clinicaltrials.gov; trial identifier: NCT00285012).
authors.affiliation: Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095-1690, USA.
authors.forename: D P
authors.initials: DP
authors.lastname: Tashkin
authors.forename: S
authors.initials: S
authors.lastname: Rennard
authors.forename: J
authors.initials: J
authors.lastname: Taylor Hays
authors.forename: D
authors.initials: D
authors.lastname: Lawrence
authors.forename: J P
authors.initials: JP
authors.lastname: Marton
authors.forename: T C
authors.initials: TC
authors.lastname: Lee
mesh_terms: D001552:Benzazepines / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D029424:Pulmonary Disease, Chronic Obstructive / Q000503:physiopathology* / Q000523:psychology; D011788:Quality of Life; D011810:Quinoxalines / Q000008:administration & dosage* / Q000009:adverse effects; D016540:Smoking Cessation / Q000379:methods; D013147:Spirometry; D011795:Surveys and Questionnaires; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline