Abstract | BACKGROUND: OBJECTIVE: This study assessed the long-term efficacy and tolerability of budesonide/ formoterol HFA pMDI in patients with moderate to very severe COPD. METHODS: This was a 12-month, randomized, double-blind, double-dummy, parallel-group, active- and placebo-controlled, multicentre study (NCT00206167) of 1, 964 patients aged >or =40 years with moderate to very severe COPD conducted from 2005 to 2007 at 237 sites in the US, Europe and Mexico. After 2 weeks of treatment based on previous therapy (ICSs, short-acting bronchodilators allowed), patients received one of the following treatments twice daily: budesonide/ formoterol pMDI 160/4.5 microg x two inhalations (320/9 microg); budesonide/ formoterol pMDI 80/4.5 microg x two inhalations (160/9 microg); formoterol DPI 4.5 microg x two inhalations (9 microg); or placebo. MAIN OUTCOME MEASURES: The co-primary efficacy variables were pre-dose forced expiratory volume in 1 second (FEV1) and 1-hour post-dose FEV1. RESULTS:
Budesonide/ formoterol 320/9 microg demonstrated greater improvements in pre-dose FEV1 versus formoterol (p = 0.008), and both budesonide/ formoterol doses demonstrated greater improvements in 1-hour post-dose FEV1 versus placebo (p < 0.001). The rate of COPD exacerbations was lower in both budesonide/ formoterol groups compared with formoterol and placebo (p <or= 0.004). Both budesonide/ formoterol doses were more effective than placebo (p <or= 0.006) for controlling dyspnoea and improving health status (St George's Respiratory Questionnaire). All treatments were generally well tolerated. The incidence of pneumonia was not different for active (3.4-4.0%) and placebo (5.0%) groups. CONCLUSIONS:
Budesonide/ formoterol pMDI (320/9 microg and 160/9 microg) improved pulmonary function and reduced symptoms and exacerbations over 1 year in patients with moderate to very severe COPD. Only budesonide/ formoterol pMDI 320/9 microg demonstrated greater efficacy for both co-primary variables compared with formoterol DPI 9 microg. Both budesonide/ formoterol pMDI dosages were well tolerated relative to formoterol and placebo.
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Authors | Stephen I Rennard, Donald P Tashkin, Jennifer McElhattan, Mitchell Goldman, Sulabha Ramachandran, Ubaldo J Martin, Philip E Silkoff |
Journal | Drugs
(Drugs)
Vol. 69
Issue 5
Pg. 549-65
( 2009)
ISSN: 0012-6667 [Print] New Zealand |
PMID | 19368417
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aerosol Propellants
- Bronchodilator Agents
- Drug Combinations
- Ethanolamines
- Hydrocarbons, Fluorinated
- Budesonide
- apaflurane
- Formoterol Fumarate
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Topics |
- Adult
- Aerosol Propellants
(chemistry)
- Aged
- Aged, 80 and over
- Bronchodilator Agents
(administration & dosage, adverse effects, therapeutic use)
- Budesonide
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Drug Combinations
- Ethanolamines
(administration & dosage, adverse effects, therapeutic use)
- Female
- Follow-Up Studies
- Forced Expiratory Volume
- Formoterol Fumarate
- Humans
- Hydrocarbons, Fluorinated
(chemistry)
- Male
- Metered Dose Inhalers
- Middle Aged
- Pulmonary Disease, Chronic Obstructive
(drug therapy)
- Severity of Illness Index
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