A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Methods (1)
Two hundred patients with a diagnosis of long-term bronchial asthma were screened from five centers for entry into a 16-week double-blind, group comparative study. One hundred twenty seven patients satisfied the entry criteria and following a two-week baseline were randomized using predetermined codes to receive either nedocromil sodium metered dose inhaler§ (two actuations of 2 mg, four times daily) or a matching placebo preparation (64 nedocromil sodium, 63 placebo). Three nedocromil sodium-treated patients used prednisone during the baseline in violation of the entry criteria (one was subsequently withdrawn due to uncontrolled asthma) and three patients (one—nedocromil sodium) provided no efficacy data. One hundred twenty one patients, therefore, form the basis of the efficacy analysis (Table 1).
All patients were maintained on daily SRT (62 percent Theo-Dur), adjusted if necessary to a therapeutic level, and prn inhaled 02 (65 percent albuterol, 30 percent metaproterenol). Thirteen percent required oral p2. Four patients (three placebo) had required oral corticosteroids and five (two placebo) had used cromolyn sodium within six months of the study.
Table 1—Patient Characteristics
|Number of patients||60||61|
|\ge, yr mean||35.5||34.9|
|Duration, yr mean||21.3||20.2|
|Immunotherapy during study||14||6|
|FEV, (mean % predicted normal)||67.0||65.0|
|FEV, (liters): mean (range)|
|at admission||2.55 (0.85-5.63)||2.27 (0.71-4.73)|
|end of baseline||2.37 (0.85-3.96)||2.34 (1.00-4.36)|
|% Reversibility FEV, with ^-agonist: mean (range)|
|at admission||36.7 (13.0-99.0)||33.5 (11.0-93.0)|
|end of baseline||30.8 (5.7-101.1)||26.2 (-16.7-85.5)|