Asthma Severity: Baseline clinic assessment of asthma severity (mild to moderate) was very similar between the two treatment groups (Table 2). Asthma severity did not differ significantly (p>0.05) between the treatment groups at the week 4, 5, or 6 assessmerits, although there was a trend toward a decrease in severity in nedocromil sodium-treated patients and an increase in severity in placebo-treated patients. The withdrawal of theophylline therapy led to an increase in severity in the majority of the placebo-treated patients (n = 12), but no change in the majority of the nedocromil sodium-treated patients (n = 13) (p<0.05; week 8). Severity assessment at week 8 indicated a greater shift to moderately severe asthma in the placebo-treated patients.Clinical Comment: In terms of symptom control, theophylline reduction was significantly (p<0.001) better tolerated by the nedocromil sodium group compared with the placebo group. All 18 nedocromil sodium-treated patients were able to partly (14 patients) or completely (four patients) reduce theophylline. Two placebo-treated patients could partly reduce theophylline; the remainder (15 patients), not at all. The clinicians considered that theophylline withdrawal was well tolerated by five patients (three receiving nedocromil sodium; two receiving placebo) but in 15 patients in each treatment group, withdrawal led to a worsening of symptoms. itat on
Pulmonary Function Tests: In the nedocromil sodium group, FEVi (Table 3), PEF, and FVC remained fairly constant during the treatment phase, although PEF and FVC deteriorated slightly as a result of withdrawal of theophylline therapy ( — 3.1 percent and —2.4 percent, respectively; week 8). Reduction and withdrawal of theophylline therapy led to a progressive deterioration in all pulmonary function variables in the placebo-treated group (week 8: PEF —13.7 percent, FEV, —15 percent, FVC —8.3 percent), the between-treatment difference being significant (p^ 0.05) for FEVt at all treatment clinic visits (Table 3).
Table 2—Asthma Severity at Baseline and at Week 8
Table 3—FEV, at Clinic Visits (Mean±SEM)
|Baseline (BL)||2.74 ±0.15||3.08 ±0.20||0.18|
|Week 4—BL||0.18 ±0.12||— 0.11±0.07||0.05|
|Week 5—BL||0.04±0.11||-0.26 ±0.06||0.03|
|Week 8—BL||0.08 ±0.17||-0.46 ±0.07||0.01|