Medicine of the Future in America

A 1-Week Dose-Ranging Study of Inhaled Salmeterol in Patients With Asthma: Evaluation Methods

Patients were seen by a physician at three office visits, ie, one screening visit and two treatment period visits (treatment days 1 and 8). At the screening visit (7 to 14 days prior to treatment day 1), patients underwent physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests. The investigator’s assessment of the patient’s asthma symptom severity was also recorded. Patients discontinued use of bronchodilators, including theophylline, for sufficient times prior to screening and on treatment day 1 to enable medication-free determinations of pulmonary function. Patients were excluded if they had taken oral corticosteroids within 4 weeks or cromolyn or inhaled corticosteroids within 2 weeks prior to screening.
At treatment day 1, patients were randomly assigned to receive one of four dosage regimens of salmeterol (12.5, 25, 50, 100 Mg> resulting in actuated doses of 10.5 Mg, 21 /ig, 42 Mg, 84 Mg, respectively) or placebo every 12 h for 1 week. As all patients could use albuterol by metered-dose inhaler (MDI) as back-up medication to relieve breakthrough symptoms during the treatment period, the placebo group was essentially an albuterol “as-needed” control group. more The double-blind was maintained by providing patients with two MDIs containing either active drug or placebo; patients self-administered the study medications by inhaling two puffs from each of two canisters in the morning and 12 h later. During the treatment period, treatment with all asthma medications other than study medication and back-up albuterol was discontinued, including corticosteroids, cromolyn, and theophylline.
Serial pulmonary function tests (FEVi, FEF25-75%, and FVC) were performed twice predose (30 min before and immediately before dosing) and at 10 postdose times over a 12-h period on treatment days 1 and 8. In addition, at the screening visit, each patient received a peak flow meter with instructions to record on diary cards the best of three successive determinations of peak expiratory flow (PEF) every morning before the first dose of study drug and every evening before the last dose of study drug; this was done during the screening period and during treatment. Patients also recorded the presence and severity (0=none to 3=severe) of asthma symptoms (shortness of breath, chest tightness, coughing, and wheezing), the number of times per night that they were awakened as the result of asthma symptoms, and the number of puffs of supplemental albuterol used each day.

This entry was posted in Asthma and tagged asthma, bronchodilator, salmeterol, theophylline.
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