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November 16, 1994

Effects of Smoking Intervention and the Use of an Inhaled Anticholinergic Bronchodilator on the Rate of Decline of FEV1: The Lung Health Study

Nicholas R. Anthonisen, MD; John E. Connett, PhD; James P. Kiley, PhD; et al Murray D. Altose, MD; William C. Bailey, MD; A. Sonia Buist, MD; William A. Conway Jr, MD; Paul L. Enright, MD; Richard E. Kanner, MD; Peggy O'Hara, PhD; Gregory R. Owens, MD; Paul D. Scanlon, MD; Donald P. Tashkin, MD; Robert A. Wise, MD; M. D. Altose, MD; A. F. Connors, MD; S. Redline, MD; C. Deitz, PhD; R. F. Rakos, PhD; W. A. Conway Jr, MD; A. DeHorn, PhD; J. C. Ward, MD; C. S. Hoppe-Ryan, CSW; R. L. Jentons, MA; J. A. Reddick, RN; C. Sawicki, RN, MPH; R. A. Wise, MD; S. Permutt, MD; C. S. Rand, PhD; P. D. Scanlon, MD; L. J. Davis, PhD; R. D. Hurt, MD; R. D. Miller, MD; D. E. Williams, MD; G. M. Caron; G. G. Lauger, MS; S. M. Toogood; A. S. Buist, MD; W. M. Bjornson, MPH; L. R. Johnson, PhD; W. C. Bailey, MD; C. M. Brooks, EdD; J. J. Dolce, PhD; D. M. Higgins; M. A. Johnson; C. D. Lorish, PhD; B. A. Martin; D. P. Tashkin, MD; A. H. Coulson; H. Gong, MD; P. I. Harber, MD; V. C. Li, PhD, MPH; M. Roth, MD; M. A. Nides, PhD; M. S. Simmons; I. Zuniga; N. R. Anthonisen, MD; J. Manfreda, MD; R. P. Murray, PhD; S. C. Rempel-Rossum; J. M. Stoyko; J. E. Connett, PhD; M. O. Kjelsberg, PhD; M. K. Cowles, MS; D. A. Durkin; P. L. Enright, MD; K. J. Kurnow, MS; W. W. Lee, MS; P. G. Lindgren, MS; S. J. Mongin, MS; P. O'Hara, PhD; H. T. Voelker; L. A. Waller, PhD; G. R. Owens, MD; R. M. Rogers, MD; J. J. Johnston, PhD; F. P. Pope, MSW; F. M. Vitale, MA; R. E. Kanner, MD; M. A. Rigdon, PhD; K. C. Benton; P. M. Grant; M. Becklake, MD; B. Burrows, MD; P. Cleary, PhD; P. Kimbel, MD; L. Nett, RN, RRT; J. K. Ockene, PhD; R. M. Senior, MD; G. L. Snider, MD; W. Spitzer, MD; O. D. Williams, PhD; S. S. Hurd, PhD; J. P. Kiley, PhD; M. C. Wu, PhD; S. M. Ayres, MD; R. E. Hyatt, MD; B. A. Mason, MD
Author Affiliations

for the Lung Health Study Research Group; Case Western Reserve University, Cleveland, Ohio; Henry Ford Hospital, Detroit, Mich; Johns Hopkins University School of Medicine, Baltimore, Md; Mayo Clinic, Rochester, Minn; Oregon Health Sciences University, Portland; University of Alabama at Birmingham; University of California—Los Angeles; University of Manitoba, Winnipeg; University of Minnesota Data Coordinating Center, Minneapolis; University of Pittsburgh (Pa); University of Utah, Salt Lake City; Safety and Data Monitoring Board; National Heart, Lung, and Blood Institute staff, Bethesda, Md; Mortality and Morbidity Review Board
From University of Manitoba, Winnipeg (Dr Anthonisen); University of Minnesota, Minneapolis (Dr Connett); National Heart, Lung, and Blood Institute, Bethesda, Md (Dr Kiley); Case Western Reserve University, Cleveland, Ohio (Dr Altose); University of Alabama at Birmingham (Dr Bailey); Oregon Health Sciences University, Portland (Dr Buist); Henry Ford Hospital, Detroit, Mich (Dr Conway); University of Arizona, Tucson (Dr Enright); University of Utah, Salt Lake City (Dr Kanner); University of Miami (Fla) (Dr O'Hara); University of Pittsburgh (Pa) (Dr Owens); Mayo Clinic, Rochester, Minn (Dr Scanlon); University of California— Los Angeles (Dr Tashkin); and The Johns Hopkins University, Baltimore, Md (Dr Wise).

JAMA. 1994;272(19):1497-1505. doi:10.1001/jama.1994.03520190043033

Objective.  —To determine whether a program incorporating smoking intervention and use of an inhaled bronchodilator can slow the rate of decline in forced expiratory volume in 1 second (FEV1) in smokers aged 35 to 60 years who have mild obstructive pulmonary disease.

Design.  —Randomized clinical trial. Participants randomized with equal probability to one of the following groups: (1) smoking intervention plus bronchodilator, (2) smoking intervention plus placebo, or (3) no intervention.

Setting.  —Ten clinical centers in the United States and Canada.

Participants.  —A total of 5887 male and female smokers, aged 35 to 60 years, with spirometric signs of early chronic obstructive pulmonary disease.

Interventions.  —Smoking intervention: intensive 12-session smoking cessation program combining behavior modification and use of nicotine gum, with continuing 5-year maintenance program to minimize relapse. Bronchodilator: ipratropium bromide prescribed three times daily (two puffs per time) from a metered-dose inhaler.

Main Outcome Measures.  —Rate of change and cumulative change in FEV1 over a 5-year period.

Results.  —Participants in the two smoking intervention groups showed significantly smaller declines in FEV1 than did those in the control group. Most of this difference occurred during the first year following entry into the study and was attributable to smoking cessation, with those who achieved sustained smoking cessation experiencing the largest benefit. The small noncumulative benefit associated with use of the active bronchodilator vanished after the bronchodilator was discontinued at the end of the study.

Conclusions.  —An aggressive smoking intervention program significantly reduces the age-related decline in FEV1 in middle-aged smokers with mild airways obstruction. Use of an inhaled anticholinergic bronchodilator results in a relatively small improvement in FEV1 that appears to be reversed after the drug is discontinued. Use of the bronchodilator did not influence the long-term decline of FEV1.(JAMA. 1994;272:1497-1505)