| Abstract | RATIONALE: Arformoterol, a single isomer long-acting beta(2)-agonist, was developed as an inhalation solution for the maintenance treatment of bronchoconstriction in COPD. METHODS: The pulmonary function efficacy of nebulized arformoterol (15 micro g BID, 25 micro g BID, 50 micro g QD) and salmeterol MDI (42 micro g BID) versus placebo was assessed in 1456 subjects (mean FEV(1) 1.2L, mean predicted 41%). Data were pooled from 2 identical, 12-week, double-blind, randomized trials. The percent change in trough FEV(1), percent change in FEV(1) average AUC((0 - 12 hrs)) and peak percent change FEV(1) from predose were analyzed. RESULTS: Improvement in trough FEV(1) averaged over 12 weeks was greater for arformoterol and salmeterol versus placebo (mean differences from placebo [95% CI] arformoterol-15 micro g BID: 11.4% [8.4, 14.3]; 25 micro g BID: 15.4% [12.2, 18.6]; 50 micro g QD: 10.9% [7.9, 13.9]); salmeterol: (11.6% [8.8, 14.4]). Greater improvements versus placebo occurred after the first dose (mean differences between arformoterol and placebo for trough FEV(1): 13-19%; FEV(1) AUC((0 - 12 hrs)): 19-24%; peak percent change: 20-25%) and at week 12 (trough FEV(1): 10-13%; FEV(1) AUC((0 - 12 hrs)): 6-13%; peak percent change: 7-14%); all 95% CIs excluded zero. Increases in FEV(1) AUC((0 - 12 hrs)) and peak percent change were greater for arformoterol than for salmeterol (95% CIs excluded zero). After 12 weeks, 78-87% of arformoterol subjects had > or = 10% increases in FEV(1) from pre-dose (56% salmeterol, 44% placebo); the median time to response was 3-13 minutes (142 minutes salmeterol). CONCLUSIONS: In these trials, COPD subjects administered nebulized arformoterol demonstrated significant and sustained improvement in lung function over 12 weeks. |
| Authors | John P Hanrahan, Nicola A Hanania, William J Calhoun, Steven A Sahn, Kenneth Sciarappa, Rudolf A Baumgartner
(Affiliation: Sepracor Inc., Marlborough, MA 01752, USA. john.hanrahan at sepracor.com)
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| Journal | COPD
(COPD)
Vol. 5
Issue 1
Pg. 25-34
(Feb 2008)
ISSN: 1541-2555 United States |
| PMID | 18259972
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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| Chemical References |
- Bronchodilator Agents
- Ethanolamines
- formoterol
|
| Topics |
- Administration, Inhalation
- Bronchoconstriction
(drug effects, physiology)
- Bronchodilator Agents
(administration & dosage)
- Double-Blind Method
- Ethanolamines
(administration & dosage)
- Female
- Follow-Up Studies
- Forced Expiratory Volume
(drug effects, physiology)
- Humans
- Male
- Middle Aged
- Nebulizers and Vaporizers
- Pulmonary Disease, Chronic Obstructive
(drug therapy, physiopathology)
- Single-Blind Method
- Treatment Outcome
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