ROUTINE NEBULIZED IPRATROPIUM AND ALBUTEROL TOGETHER ARE BETTER THAN EITHER ALONE IN COPD

Study objective: We compared the long-term safety and efficacy of the combination ipratropium bromide (IB) and albuterol sulfate (ALB) inhal ation solution with that of each separate component using three-times- daily administration. Design: Using a parallel design, we randomized p atients to receive 3.0 mg ALB, 0.5 mg IB, or the combination by small- volume nebulizer (SVN) for 85 days. Subjects were allowed to use up to two extra doses of study medication daily for control of symptoms on an as-needed basis. The main efficacy evaluation was the acute pulmona ry function response to an aerosol of the maintenance study medication over the course of the investigation. Physician global evaluation, su bject quality of life assessments, COPD symptom scores, and twice-dail y peak expiratory flow rate (PEFR) were also assessed over the study p eriod. Setting: Twenty-five centers participated in the investigation. Patients: We studied 652 patients with moderate to severe COPD. Measu rements and results: Over the course of the study, the acute spirometr ic response and evening PEFR values with the SVN combination of IB plu s ALB were statistically significantly better compared to ALB or IB al one. The quality of life scores, physician global evaluations, symptom scores, and morning PEFR scores were unchanged over the duration of t he study in all treatment groups. There was no significant difference in adverse events in the three treatment groups. Conclusions: In patie nts with COPD, maintenance SVN therapy with IB and ALB provides better bronchodilation than either therapy alone without increasing side eff ects.