A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Results (4)

A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Results (4)Clinic assessment of asthma severity was similar between the two treatment groups at the end of the baseline (Table 3). There was a statistically significant difference (p = 0.01) in favor of the nedocromil sodium-treated patients by the end of week 2, ie, before the withdrawal of SRT, with a mean improvement from baseline of greater than 0.5. This difference was statistically highly significant (p<0.001) at week 6, four weeks after SRT, were withdrawn, and remained so until the end of the study (Table 3) when the majority of nedocromil sodium-treated patients were assessed as having mild, moderately mild, or no apparent disease, the difference between treatment groups being approximately one point on the severity scale. buy ortho tri-cyclen online

The clinicians’ and patients* evaluations of treatment showed a significant difference (p<0.001) in favor of nedocromil sodium (Table 4). The clinicians found nedocromil sodium to be very, moderately, or slightly effective in 50 of the 60 patients (83 percent) and placebo to be similarly effective in 27 patients (44 percent). Patient assessments were the same; 85 percent (51) found nedocromil sodium effective and 43 percent (26) found placebo effective.

Table 3—Clinicians Assessment of Asthma Severity— Visit Means

Treatment (Sample Size)
Time Nedocromil Significance,t
(Visit Number) Sodium Placebo p-value
Baseline (2) 2.60 (60) 2.54 (61) 0.77
Study week:
2 (3) 2.07 (60) 2.44 (61) 0.01
6 (4) 1.68 (60) 2.92 (61) <0.001
10 (5) 1.78 (60) 2.85 (59) 0.002
14 (6) 1.92 (60) 2.78 (58)$ 0.005

Table 4—Final Assessment of Efficacy

Assessment Clinicians Patients
NedocromilSodium Placebo NedocromilSodium Placebo
Very effective 25 8 16 8
Moderately effective 15 14 24 10
Slightly effective 10 5 11 8
No effect 8 19 7 21
Made asthma worse 1 2 1 1
Therapeutic failure 1 12 1 12
Significance, p-valuet p<0.001 p<0.001

Category: Pulmonary function

Tags: asthma, bronchodilator, nedocromil sodium, pulmonary function