Therapy with a beta2-agonist/anticholinergic combination via nebulization or MDI is commonly used to treat COPD. This study compared the use of fixed combination products with different modes of administration and the concomitant use of the two administration methods in the management of COPD.
Approximately 120 patients were enrolled in a 12-week, single-blinded study randomized across 15 sites into one of three parallel treatment arms: (1) albuterol 3.0mg/ ipratropium 500mcg premixed UD solution (alb/ipra UD) via nebulizer 4 times daily or (2) alb/ipra MDI 4 times daily, or (3) alb/ipra UD via nebulizer in the morning and at bedtime with concomitant use of alb/ipra MDI afternoon and evening. The MDI group is compared to both the premixed UD solution and the concomitant group. The primary outcome is Quality of Life (QOL) measured by the St. George Respiratory Questionnaire (SGRQ) at baseline, 6-weeks, and 12-weeks. Secondary efficacy measures include 1-hr post-bronchodilator FEV1, peak flow, patient symptom scores, use of rescue medication, and a validated Treatment Satisfaction Questionnaire.
Preliminary results from 20 patients who completed 6-weeks of treatment indicate that there was an 8-point difference between the mean SGRQ scores for 10 patients using the concomitant nebulizer/MDI treatment compared to 10 patients who used the MDI treatment, in favor of concomitant therapy. The use of rescue medication was also reduced in this group. Confirmation of the preliminary results and its statistical significance will be reported at the meeting.
These preliminary data suggest that a therapeutic regimen of concomitant nebulizer/MDI can lead to meaningful QOL improvements in COPD patients.
The QOL of COPD patients treated with alb/ipra MDI may be enhanced by concomitant use of premixed UD nebulized alb/ipra in the morning and night.
D. Tashkin, Study is sponsored by Dey, LP