OBJECTIVE: To determine whether smoking intervention and use of an inhaled bronchodilator can slow the rate of decline in forced expiratory volume in 1 s (FEV1) in smokers with mild obstructive pulmonary disease.DESIGN: Randomized clinical trial: participants randomized to one of three groups: smoking intervention plus inhaled bronchodilator (Atrovent; ipratropium bromide) (SIA): smoking intervention plus placebo (SIP); or no intervention (usual care, UC).SETTING: Ten centres in the United States and Canada.PARTICIPANTS: A total of 5887 smokers, aged 35 to 60 years, with FEV155 to 90% predicted and FEV1/forced vital capacity (FVC) less than 70%.INTERVENTIONS: Smoking intervention: intensive program combining behaviour modification and use or nicotine gum, with a subsequent maintenance program to prevent relapse. Bronchodilator: ipratropium bromide, two puffs three times daily from a metered dose inhaler.MAIN OUTCOME MEASURES: Change in FEV1over a five-year period.RESULTS: Sustained smoking cessation was achieved in 22% of both intervention groups (SIA, SIP), compared with 5% in UC. Both SIA and SIP groups showed significantly smaller declines in postbronchodilator FEV1over the five years of the study - 184 mL and 209 mL, respectively. compared with 267 mL in UC. This difference was accounted for by an increase in FEV1in the SIA (+39 mL) and SIP (+11 mL) groups in the first year of the study, compared with a decline in UC (-34 mL). Those who achieved sustained smoking cessation experienced the greatest benefit, evident for the five years of study. There was a small noncumulative benefit associated with use of the active bronchodilator, which disappeared after the bronchodilator was discontinued.CONCLUSIONS: An effective smoking intervention program significantly reduced decline in FEV1in smokers with mild airways obstruction. Use of an inhaled anticholinergic bronchodilator did not influence the long term decline of FEV1.
Effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of FEV1. The Lung Health Study