LHS II recruited 1,116 participants at 10 clinical centers in the United States and Canada. These were individuals who participated in LHS I (1,018 persons) or were screened for LHS I (98 persons), and were still smoking or had recently quit (< 2 years). Enrollment took place from November 1994 to November 1995. Other inclusion criteria were age between 40 and 69 years, and the presence of airflow obstruction (FEV1/FVC ratio, < 0.70; FEV1, between 30% and 90% of predicted normal values). Participants were excluded from the study if they had used ICSs or oral corticosteroids within 6 months, or if they had a medical condition that might interfere with participation in the trial. No participants reported using prescribed oral anticoagulants at baseline. Baseline characteristics were determined prior to randomization. Participants were randomized with equal probability to receive either TAA (six puffs bid [1,200 |j,g per day]), or a placebo of identical appearance. Participants and study staff were unaware of the study drug assignments. The methods and detailed entry criteria have been described elsewhere. avandia online
Participants returned every 3 months to obtain new inhalers and to report respiratory symptoms or potential side effects. Compliance with the inhaled study drug was measured at each 3-month visit by questioning the participants and by weighing returned canisters, as previously described. Canisters were weighed before being dispensed and when they were returned using the same digital electronic scale. The weight difference divided by the number of days between canister issue and canister return was used to calculate mean daily usage. At 6-month intervals, inhaler technique was observed and counseling was provided to improve inhaler technique or compliance, as necessary.