Abstract
The efficacy and safety of nedocromil sodium inhalation aerosol (4 mg** * Each actuation delivers 2 mg ex-valve and 1.75 mg from the mouthpiece.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 All maintenance bronchodilators were withdrawn before the baseline period, and patients entered the treatment period only after demonstrating a specified level of asthma symptoms.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 β2-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. (J ALLERGY C LIN IMMUNOL 1995;95:829-36.).
Original language | English (US) |
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Pages (from-to) | 829-836 |
Number of pages | 8 |
Journal | The Journal of allergy and clinical immunology |
Volume | 95 |
Issue number | 4 |
DOIs | |
State | Published - Apr 1995 |
Externally published | Yes |
Keywords
- Asthma
- antiinflammatory
- nedocromil sodium
- pyranoquinoline
- twice daily dosing
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology