By Maggie Schwarz
PHILADELPHIA -- November 3, 2008 -- Twice-daily formoterol fumarate inhalation solution is as effective and longer lasting than the combination of ipratropium bromide and albuterol sulfate 4 times daily in patients with chronic obstructive pulmonary disease (COPD), according to results of a randomised, double-blind, crossover study.
"Not only was albuterol longer-acting than ipratropium/albuterol, but patients felt more satisfied with it and more in control of their disease," stated investigator E. Rand Sutherland, MD, MPH, University of Colorado Health Sciences Center, Denver, Colorado.
Dr. Sutherland and colleagues compared the efficacy of nebulised formoterol with that of ipratropium/albuterol as maintenance treatment in patients with COPD. He presented the results on October 29 at CHEST 2008, the annual meeting of the American College of Chest Physicians.
Short-acting bronchodilators include beta-agonists (albuterol) and anticholinergics (ipratropium) that require dosing up to 4 times daily. Long-acting bronchodilators include beta-agonists (formoterol) that are fast acting, have a long duration of action and can be administered twice daily. Fixed-dose ipratropium/albuterol combination provides more effective bronchodilation than either agent alone, Dr. Sutherland explained. A long-acting beta-agonist has yet to be compared with ipratropium/albuterol.
The researchers conducted an efficacy analysis on 99 patients aged 62 +- 10 years. The cohort was equally divided between men and women.
After 2 weeks of treatment, forced expiratory volume at 1 second (FEV1) was greater in the formoterol group than in the ipratropium/albuterol group (P = .001). Peak FEV1 levels and standardised FEV1 area under the curve at 0 to 6 hours (AUC0-6) were similar between groups. FEV1 was significantly higher on day 1 at 6 hours and day 14 at 4 and 6 hours after formoterol treatment than ipratropium/albuterol (P <= .0004).
Baseline/transition dyspnoea index scores were similar between treatment groups and indicated moderate dyspnoea. Both formoterol and ipratropium/albuterol provided clinically meaningful improvement in dyspnoea scores.
Patients perceived more control of their COPD using twice-daily formoterol (P < .007), Dr. Sutherland said. When questioned about their satisfaction with the medications, patients reported greater satisfaction with their response to formoterol than to ipratropium/albuterol (P < .013). Formoterol resulted in a distribution of responses showing increased perception that the medication went into the lungs versus ipratropium/albuterol (P < .028).
Use of albuterol rescue medication, rates of nighttime awakenings, and incidence of adverse events were similar between the treatment groups.
Dr. Sutherland concluded that nebulised formoterol provided comparable bronchodilation to ipratropium/albuterol, with a significantly longer duration of action and superior morning pre-dose FEV1 in patients with COPD.
Formoterol BID also provided greater treatment satisfaction and perception of increased disease control than ipratropium/albuterol 4 times daily, he said.
Funding for this study was provided by Supported by Dey LP.
[Presentation title: In COPD, Nebulized Formoterol Fumarate Provides Prolonged Bronchodilation and Increased Patient Satisfaction Compared to Albuterol/Ipratropium MDI. Abstract AP2236]
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