13 Sep

Effect of Long-term Salmeterol Therapy Compared With As-Needed Albuterol Use on Airway Hyperresponsiveness: Pulmonary Function Tests

Effect of Long-term Salmeterol Therapy Compared With As-Needed Albuterol Use on Airway Hyperresponsiveness: Pulmonary Function TestsPulmonary Function Tests
Morning predose FEV1 values were increased significantly over baseline in the salmeterol group at all treatment assessments when compared to the placebo group. With salmeterol, increases of 0.21, 0.23, 0.25, 0.23, 0.23, and 0.26 L above baseline were observed after weeks 4, 8, 12, 16, 20, and 24, respectively, when compared to placebo, where change in FEV1 ranged from —0.03 L at week 4 to 0.08 L at week 24 (p < 0.001). In the salmeterol group, FEV1 values obtained at posttreatment days 3 and 7 returned to near baseline levels (0.03 and 0.06 L, respectively, change from baseline) and were not significantly different from placebo (0.07 and 0.04 L, respectively, change from baseline).
Asthma Symptom Scores
For the overall treatment period (weeks 1 through 24), the use of salmeterol reduced mean symptom scores for wheezing, shortness of breath, and chest tightness by 20%, 18%, and 16% from baseline when compared to decreases from baseline of 3%, 3%, and 7% in the placebo group, respectively (Table 3). The percentage change from baseline differences in symptom scores for wheezing, shortness of breath, and chest tightness for salmeterol compared with placebo were significant (p < 0.042). The percentage of symptom-free days was increased significantly (29%) from baseline in the salmeterol group when compared to the placebo group (10%); (p < 0.001). add comment

Nighttime Awakenings
At baseline, patients in both the salmeterol and placebo groups reported that on 78% of the nights they had no awakenings attributed to asthma symptoms. During the treatment period, use of salmeterol significantly increased the percentage of nights with no awakenings by 18% from baseline when compared to an 8% increase in the placebo group (Table 3).
Supplemental Albuterol Use
During the baseline period, patients in the salmeterol group used an average of 2.98 puffs per day of supplemental albuterol compared with an average of 2.83 puffs per day in the placebo group (p = 0.502). Mean (SEM) daily use of supplemental albuterol over treatment weeks 1 through 24 decreased by 51% to 1.48 (0.11) puffs per day in the salmeterol group when compared with a 12% decrease to 2.47 (0.18) puffs per day in the placebo group (Table 3). During the posttreatment week, supplemental albuterol use was not significantly different between the treatment groups.

Table 3—Mean Change From Baseline in Symptom Scores, Nighttime Awakenings, and Supplemental Albuterol Use Over 24 Weeks of Treatment

Salmeterol Group Placebo Group
Variables Baseline Change Baseline Change p Valuef
Subject-rated symptoms
Wheezing 0.83 (0.05) -0.29 (0.04) 0.88 (0.05) -0.08 (0.04) 0.007
Shortness of breath 1.00 (0.06) -0.32 (0.04) 1.03 (0.05) – 0.11 (0.04) 0.001
Chest tightness 0.92 (0.06) – 0.31 (0.04) 1.07 (0.05) -0.16 (0.04) 0.064
Total 0.91 (0.05) -0.31 (0.04) 0.99 (0.05) -0.12 (0.03) 0.009
Symptom-free days, % 26.3 (2.4) 20.9 (2.1) 23.4 (2.2) 7.6 (1.9) < 0.001
Nights with no awakening, % 78.0 (2.2) 11.2 (1.7) 78.2 (2.0) 3.1 (1.3) 0.004
Supplemental albuterol use, puffs/d 2.98 (0.18) -1.53 (0.15) 2.83 (0.19) -0.35 (0.13) < 0.001

Categories: Airway
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