—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.
—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.
—Ten clinical centers in the United States and Canada.
—A total of 5887 male and female smokers, aged 35 to 60 years, with spirometric signs of early chronic obstructive pulmonary disease.
—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.
—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.
—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)
Anthonisen NR, Connett JE, Kiley JP, Altose MD, Bailey WC, Buist AS, Conway WA, Enright PL, Kanner RE, O'Hara P, Owens GR, Scanlon PD, Tashkin DP, Wise RA, Altose MD, Connors AF, Redline S, Deitz C, Rakos RF, Conway WA, DeHorn A, Ward JC, Hoppe-Ryan CS, Jentons RL, Reddick JA, Sawicki C, Wise RA, Permutt S, Rand CS, Scanlon PD, Davis LJ, Hurt RD, Miller RD, Williams DE, Caron GM, Lauger GG, Toogood SM, Buist AS, Bjornson WM, Johnson LR, Bailey WC, Brooks CM, Dolce JJ, Higgins DM, Johnson MA, Lorish CD, Martin BA, Tashkin DP, Coulson AH, Gong H, Harber PI, Li VC, Roth M, Nides MA, Simmons MS, Zuniga I, Anthonisen NR, Manfreda J, Murray RP, Rempel-Rossum SC, Stoyko JM, Connett JE, Kjelsberg MO, Cowles MK, Durkin DA, Enright PL, Kurnow KJ, Lee WW, Lindgren PG, Mongin SJ, O'Hara P, Voelker HT, Waller LA, Owens GR, Rogers RM, Johnston JJ, Pope FP, Vitale FM, Kanner RE, Rigdon MA, Benton KC, Grant PM, Becklake M, Burrows B, Cleary P, Kimbel P, Nett L, Ockene JK, Senior RM, Snider GL, Spitzer W, Williams OD, Hurd SS, Kiley JP, Wu MC, Ayres SM, Hyatt RE, Mason BA. Effects of Smoking Intervention and the Use of an Inhaled Anticholinergic Bronchodilator on the Rate of Decline of FEV1The Lung Health Study. JAMA. 1994;272(19):1497-1505. doi:10.1001/jama.1994.03520190043033