A Comparative Study of the Clinical Efficacy of Nedocromil Sodium and Placebo
| Autor: | Debra Myers, Lawrence Repsher, Gregory Owens, Raymond Brady, Lyndon E. Mansfield, Paul Ratner, Malcolm N Blumenthal, Howard J. Schwartz, Sheldon Braun, Andre Van As, Michael F. Mullarkey, Richard Lockey |
|---|---|
| Rok vydání: | 1996 |
| Předmět: |
Pulmonary and Respiratory Medicine
Nedocromil business.industry medicine.drug_class Cromolyn Sodium Critical Care and Intensive Care Medicine medicine.disease Placebo respiratory tract diseases FEV1/FVC ratio Anesthesia Bronchodilator medicine Theophylline Nedocromil Sodium Cardiology and Cardiovascular Medicine business Asthma medicine.drug |
| Zdroj: | Chest. 109:945-952 |
| ISSN: | 0012-3692 |
| Popis: | 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 shewed 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 1 , 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. |
| Databáze: | OpenAIRE |
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