09 Sep

Effect of Long-term Salmeterol Therapy Compared With As-Needed Albuterol Use on Airway Hyperresponsiveness: Study Design

Effect of Long-term Salmeterol Therapy Compared With As-Needed Albuterol Use on Airway Hyperresponsiveness: Study DesignFollowing randomization, methacholine challenge tests were performed after 4, 12, and 24 weeks of treatment, and at 3 and 7 days of posttreatment. contraceptive pills

The same standardized methacholine challenge equipment and procedures were used at all investigational sites. Pulmonary function tests were performed on the initial treatment day, after 4, 8, 12, 16, 20, and 24 weeks of treatment, and at 3 and 7 days posttreatment. The use of the blinded study drug was recorded daily on diary cards. Subjects were instructed to administer two inhalations from their blinded study inhaler each morning between 6:00 am and 9:00 am and every evening between 6:00 pm and 9:00 pm. The use of spacers was not allowed. The study drug was withheld for 10 to14 h prior to pulmonary function and methacholine challenge testing, and supplemental albuterol was withheld for at least 8 h prior to these evaluations. Methacholine challenge tests were rescheduled if any of the following occurred: influenza vaccination or respiratory tract infection within 6 weeks, asthma exacerbation treated with oral steroids within 2 weeks, or asthma exacerbation not requiring oral steroids within 5 days.
Exacerbations were defined as asthma symptoms requiring treatment with medications other than albuterol MDI and the blinded study drug. Patients were not allowed use of inhaled corticosteroids, nedocromil, or cromolyn during the study. Subjects who required parenteral corticosteroids or initiation of inhaled corticosteroids, nedocromil, or cromolyn for treatment of exacerbations were withdrawn from the study. Theophylline, nebulized short-acting P-ago-nists, and oral corticosteroids (prednisone, > 60 mg qd or equivalent) were allowed for the treatment of exacerbations as long as treatment duration was < 7 days.

Categories: Airway
Tags: , , ,

© 2008 HIV/AIDS News & Information