Background: The design and results of the initial intervention program of the Lung Health Study are presented for 3,923 male and female participants. One of the major aims of this clinical trial was to achieve smoking cessation early in the study and to provide intensive follow-up procedures for maintaining abstinence. In addition, compliance with use of aerosolized inhalers (either placebo or active bronchodilator) would be necessary in order to achieve the trial goal of improved pulmonary function.
Results: Eighty-eight percent of the special intervention participants attended the 4-month follow-up visit. Forty-six percent reported not smoking from quit day through the visit, and an additional 13% had stopped smoking at the end of 4 months, although they had not achieved abstinence since quit day. The aerosol inhaler compliance was self-reported at 81% at the 4-month visit. Validating the self-reports by weighing canisters reduced the "good" compliance rates to 66%.
Conclusions: The intensive behavioral program was effective in achieving high initial rates of smoking cessation and inhaler compliance. Use of nicotine gum appeared to be an effective adjunct to the multicomponent behavioral program. Smoking status does appear to be related to inhaler compliance among both men and women participants.