ABSTRACT
The efficacy and safety of nedocromil sodium inhalation aerosol (4 mg of Tilade administered by metered-dose inhaler) given twice daily was compared with placebo in 112 patients with mild-to-moderate asthma who had been receiving maintenance therapy with oral or inhaled bronchodilators or both. After a 2-week run-in period and a subsequent 2-week baseline period, patients were randomized to active treatment (n = 56) or placebo (n = 56) for 8 weeks. All maintenance bronchodilators were withdrawn before the baseline period, and patients entered the treatment period only after demonstrating a specified level of asthma symptoms. Twice daily administration of nedocromil sodium improved all asthma symptoms in these patients who had symptoms as a result of the withdrawal of their maintenance theophylline and/or oral and inhaled beta 2-agonist bronchodilators. During the primary time period (treatment weeks 5 to 8), statistically significant between-group differences favored nedocromil sodium for the asthma summary score (primary variable, p = 0.001), daytime asthma (p = 0.001), and sleep difficulty caused by asthma (p = 0.006). Furthermore, significant reductions in the use of as-needed rescue medications were reported in the nedocromil sodium group (p = 0.003) compared with the placebo group. Final overall opinions of treatment effectiveness expressed by physicians (p = 0.016) and patients (p = 0.002) strongly favored nedocromil sodium.
Subject(s)
Asthma/drug therapy , Nedocromil/administration & dosage , Administration, Inhalation , Adolescent , Adult , Aged , Asthma/physiopathology , Double-Blind Method , Drug Administration Schedule , Female , Humans , Lung/physiopathology , Male , Medical Records , Middle Aged , Nedocromil/adverse effects , Nedocromil/therapeutic use , Placebos , Respiratory Function Tests , Treatment OutcomeABSTRACT
Successful permanent endobronchial closure of a serious postpneumonectomy bronchopleural fistula is reported in a patient with a delayed diagnosis of Mycobacterium fortuitum-cheloni infection. Increasing experience, improved plugging agents, and a review of the literature suggest that in selected patients, this procedure can avoid complex repeat operations and reverse life-threatening situations. Although atypical mycobacterial infections occur with infrequency, they are difficult to treat and may lead, as in this patient, to a misdiagnosis. Operations on granulomatous tissues are prone to heal poorly, thus inviting tissue breakdown and chronic fistulas.
