08 Sep

Effect of Long-term Salmeterol Therapy Compared With As-Needed Albuterol Use on Airway Hyperresponsiveness: Materials and Methods

Study Design
Two identically designed, randomized, double-blind, placebo-controlled, parallel-group, multicenter studies involving 31 study sites were conducted in parallel. All patients provided written, informed consent prior to study entry. The protocol and consent form were approved by an institutional review board at each study site.
A run-in period lasting 15 to 30 days was conducted to determine patient eligibility and collect baseline data. Baseline was defined as the 7 days immediately prior to treatment initiation. Following the run-in period, subjects who met all eligibility criteria were randomly assigned to receive either salmeterol aerosol, 42 μg twice daily, or placebo aerosol twice daily via metered-dose inhaler (MDI). Subjects completed a 24-week treatment period followed by a 1-week posttreatment evaluation period. Subjects were provided commercially available albuterol MDI (Ventolin Inhalation Aerosol; Glaxo Wellcome Inc; Research Triangle Park, NC) for relief of acute symptoms during the run-in, treatment, and posttreatment periods.
During run-in, patients used the albuterol MDI as needed to relieve asthma symptoms; additional asthma medications were not allowed. Subjects recorded asthma-related symptoms, morning and evening peak expiratory flow (PEF), and use of supplemental albuterol daily on diary cards. Subjects measured PEF using a hand-held, mini-Wright peak flowmeter (Clement Clarke Inc.; Mason, OH). flovent inhalers

The study staff instructed the subjects in the correct use of the flowmeter, and the subject tested the instrument before leaving the office at the end of the screening visit. Each measurement during the study was performed in triplicate, and the highest value was recorded. The morning determinations were completed immediately after rising from bed and before the subject took the first dose of the study drug (including supplemental albuterol). The evening measurements were completed before taking the last dose of the study drug for the day. Daytime asthma symptoms of wheezing, shortness of breath, and chest tightness were rated using the following five-point scale: 0 = no symptoms; 1 = some symptoms present but caused no discomfort; 2 = symptoms that caused little discomfort and did not interfere with normal daily activities; 3 = symptoms that caused discomfort and interfered with at least one normal daily activity; and 4 = symptoms that caused significant discomfort and prevented normal daily activity. The mean number of nighttime awakenings due to asthma was evaluated according to the following scale: 0 = slept well; 1 = awoke once; 2 = awoke two to three times; and 3 = awoke more than three times. Patients were required to demonstrate a defined response to methacho-line challenge.

Categories: Airway
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