An Evaluation of Levalbuterol HFA in the Prevention of Exercise-Induced Bronchospasm

Figures & data

Table 1 Demographics and baseline characteristics.

	ITT population (n = 15)
Age, yr, mean (SD)	30.5 (9.0)
Male, n (%)	13 (86.7)
Race, n (%)
Caucasian	15 (100)
FEV1, (L), mean (SD)	3.8 (0.6)
% Predicted FEV1, mean (SD)	86.5 (9.2)
Maximum% decrease in FEV1 postdose/pre-challenge at screening, mean (SD)	−26.5 (7.0)
Patients with allergic rhinitis, n (%)	15 (100)
Concomitant medication during the double blind period, n (%)
Montelukast sodium	1 (6.7)
Inhaled corticosteroids	5 (33.3)
Antihistamines	2 (13.3)

Table 2 Maximum percent decrease in FEV₁ after exercise from two different baselines: postdose/pre-challenge and predose.

	Visit postdose/pre-challenge at baseline			Visit pre-dose at baseline
Patients	Screening visit (placebo)	DB-placebo	DB-levalbuterol	Screening visit (placebo)	DB-placebo	DB-levalbuterol
1	−42.6	−24.3	−0.9	−41.7	−25.8	0.0
2	−40.8	−54.1	−21.3	−40.8	−55.7	−1.5
3	−31.0	−31.6	−6.8	−31.2	−33.0	0.0
4	−30.0	−44.9	−0.2	−28.1	−42.8	0.0
5	−27.4	−30.4	−4.5	−27.8	−29.5	0.0
6	−26.4	−16.2	−12.0	−27.5	−18.3	−4.0
7	−25.6	−20.4	−8.8	−26.5	−20.8	0.0
8	−23.4	−16.3	−7.4	−21.0	−17.1	−5.7
9	−23.2	0.0	0.0	−24.6	0.0	0.0
10	−22.9	−24.1	−4.0	−21.5	−20.0	0.0
11	−21.2	−8.0	−10.6	−22.5	−7.3	−5.3
12	−21.3	−14.8	−0.5	−20.3	−15.5	0.0
13	−20.5	−17.6	0.0	−16.9	−18.3	0.0
14	−22.4	−11.7	−4.6	−20.7	−8.9	−0.6
15	−19.0	−12.7	−5.8	−19.4	−13.4	−2.5
Mean (SD)	−26.5 (7.0)	−21.8 (14.0)	−5.8 (5.8)	−26.0 (7.3)	−21.8 (14.2)	−1.3 (2.1)

*DB-placebo and DB-levalbuterol indicates the placebo or levalbuterol treatment, respectively, during the double-blind period of the study.

Figure 1 (A) Maximum percent decrease in FEV₁ for each patient from postdose/pre-challenge after treatment with placebo (DB-placebo) or levalbuterol (DB-levalbuterol) during the double-blind period for each patient. Patient numbers (see Table 2) are indicated and the solid grey lines are to aid following individual patient values. LS-mean (Least square mean) is the adjusted means for the effects in the model (see methods). (B) Percent of patients protected at 10%, 15%, and 20% is indicated.

Figure 2 The mean FEV₁ predose, postdose/pre-exercise challenge, and at each time point post-exercise after treatment with levalbuterol or placebo. The standard deviation for each point is indicated.