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(Chest. 1996;109:945-952.)
© 1996 American College of Chest Physicians

A Comparative Study of the Clinical Efficacy of Nedocromil Sodium and Placebo

How Does Cromolyn Sodium Compare as an Active Control Treatment?

Howard J. Schwartz MD, FCCP1; Malcolm Blumenthal MD, FCCP1; Raymond Brady MD1; Sheldon Braun MD, FCCP1; Richard Lockey MD1; Debra Myers MD, FCCP1; Lyndon Mansfield MD1; Michael Mullarkey MD, FCCP1; Gregory Owens MD, FCCP1; Paul Ratner MD1; Lawrence Repsher MD, FCCP1; and Andre van As MD, FCCP1

1 From Case Western Reserve University, Cleveland

Nedocromil sodium and cromolyn sodium are the only two currently available nonsteroid anti-inflammatory agents for treatment of asthma. Clinical differences between the two agents remain under continuous investigation with reports differentiating the two on the basis of atopy of the patient and reversibility of bronchoconstriction. This study investigated the efficacy of nedocromil sodium (4 mg, qid) for treatment of mild-to-moderate asthma in comparison to placebo using cromolyn sodium (2 mg, qid) as an active control treatment. Patients were primarily allergic asthmatics (with at least 15% reversibility) previously maintained on a regimen of regular bronchodilator therapy. During a 2-week run-in period, the patient's slow-release theophylline therapy was removed, and the patients were randomized to treatment after deterioration of asthma control (asthma symptom summary score of 3 for 7 of the 14 days). After 8 weeks of treatment, patients were returned to as occasion requires bronchodilator therapy, as per the 2-week baseline period. The results demonstrate that patients treated with nedocromil sodium showed statistically significant improvements during the primary time period (mean weeks 3 through 8) over placebo-treated patients as evidenced by all indexes of asthma symptoms, pulmonary function measures, and decreased bronchodilator reliance (p<0.05). Patients treated with cromolyn sodium demonstrated similar improvements over placebo-treated patients. Comparisons between nedocromil sodium and cromolyn sodium showed the two agents to be comparable in this group of primarily allergic patients with reversible disease. Between-group differences were noted for 3 of the 13 variables (nighttime asthma, FEV1, and forced expiratory flow rate between 25% and 75% of the FVC) in favor of cromolyn sodium when the data were pooled during the primary time period. The number of patients missing 1 or more days from work/school/regular activity due to asthma was significantly fewer compared with placebo, and favoring nedocromil sodium over cromolyn sodium. No differences were observed among the three treatments for adverse events. This study demonstrated that in primarily allergic patients with reversible airways disease, nedocromil sodium and cromolyn sodium are both significantly more effective than placebo for treatment of mild-to-moderate asthma.

Key Words: anti-inflammatory • asthma • cromolyn sodium • Intal • nedocromil sodium • pulmonary function • quality of life • Tilade

Submitted on May 19, 1995
Accepted on September 25, 2007




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