Abstract | OBJECTIVE: METHODS: In this randomised, double-blind, parallel-group study, 322 symptomatic patients were recruited, of which 282 were randomised to receive either salmeterol (50 microg), FP (250 microg), or SFC (50 microg/250 microg), via a single Diskus inhaler twice daily for 12 months. Outcome variables included the number of patients requiring an increase in study medication and the number experiencing 2 exacerbations during the 12-month treatment period. Airway hyper-responsiveness (AHR) and lung function tests were performed at clinic visits. Peak expiratory flow, rescue medication use, symptom scores and adverse events were recorded in diary cards. RESULTS: Fewer patients required an increase in study medication with SFC (10.5%) than with either FP (34.8%) or salmeterol (61.1%) (P<0.001). Significantly fewer patients experienced 2 exacerbations with SFC (4.2%), compared with FP (17.4%; P<0.01) or salmeterol (40%; P<0.001). SFC improved AHR to a significantly greater extent than FP ( methacholine PC20=1.8 mg/ml vs. 1.1 mg/ml; P<0.05) or salmeterol ( methacholine PC20=1.8 mg/ml vs. 0.7 mg/ml; P<0.001). CONCLUSIONS: The protection against exacerbations may be attributed to better control of inflammation, AHR and lung function parameters achieved with salmeterol and FP in combination, compared with either treatment alone.
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Authors | Bo Lundbäck, Eva Rönmark, Anne Lindberg, Ann-Christin Jonsson, Lars-Gunnar Larsson, Frank Pétavy, Mark James |
Journal | Respiratory medicine
(Respir Med)
Vol. 100
Issue 1
Pg. 2-10
(Jan 2006)
ISSN: 0954-6111 [Print] England |
PMID | 16243498
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Androstadienes
- Bronchodilator Agents
- Salmeterol Xinafoate
- Fluticasone
- Albuterol
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Topics |
- Administration, Inhalation
- Adolescent
- Adult
- Aged
- Albuterol
(administration & dosage, analogs & derivatives)
- Androstadienes
(administration & dosage)
- Asthma
(drug therapy)
- Bronchodilator Agents
(administration & dosage)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Fluticasone
- Forced Expiratory Volume
(drug effects)
- Humans
- Male
- Middle Aged
- Peak Expiratory Flow Rate
(drug effects)
- Salmeterol Xinafoate
- Vital Capacity
(drug effects)
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