The Efficacy and Safety of Combination Salmeterol (50 μg)/Fluticasone Propionate (500 μg) Inhalation Twice Daily Via Accuhaler in Chinese Patients With COPD

Autor: Jinping Zheng, Sheng-Dao Xiong, Wen-Jie Huang, Yi Shi, Shao-guang Huang, Chang-Zheng Wang, Nanshan Zhong, Lan Yang, Tie-ying Sun, Ya Mei Wu, Zhong Guang Wen, Guang-fa Wang, Ping Chen
Rok vydání: 2007
Předmět:
Adult
Male
Pulmonary and Respiratory Medicine
China
medicine.drug_class
Critical Care and Intensive Care Medicine
Placebo
Drug Administration Schedule
Statistics
Nonparametric
Fluticasone propionate
law.invention
Placebos
Pulmonary Disease
Chronic Obstructive
Double-Blind Method
Randomized controlled trial
law
Forced Expiratory Volume
Surveys and Questionnaires
Bronchodilator
Administration
Inhalation
Humans
Medicine
Albuterol
Metered Dose Inhalers
Salmeterol Xinafoate
Aged
Fluticasone
Aged
80 and over
COPD
Dose-Response Relationship
Drug
business.industry
Smoking
Middle Aged
medicine.disease
Bronchodilator Agents
respiratory tract diseases
Androstadienes
Treatment Outcome
Tolerability
Anesthesia
Quality of Life
Drug Therapy
Combination
Female
Salmeterol
Cardiology and Cardiovascular Medicine
business
medicine.drug
Zdroj: Chest. 132:1756-1763
ISSN: 0012-3692
DOI: 10.1378/chest.06-3009
Popis: Few studies of the efficacy and safety of therapy with combinations of salmeterol/fluticasone propionate (SFCs) have been conducted in Chinese patients with COPD, and the benefits of combination therapy in nonsmoking patients with COPD are, to our knowledge, not known.The aims were to establish the efficacy and tolerability of the therapy with SFC (salmeterol, 50 microg/fluticasone, 500 microg, twice daily) in the management of Chinese COPD patients and to investigate the effectiveness of SFC in nonsmokers with COPD.This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Changes in prebronchodilator and postbronchodilator FEV(1), quality of life determined by the St. George Respiratory Questionnaire (SGRQ) scores, relief bronchodilator use, nighttime awakenings, and frequency of exacerbations of COPD were measured in patients randomized to receive SFC (n = 297) or placebo (n = 148). Never-smokers, former smokers, and current smokers accounted for 11.7%, 66.7%, and 21.6%, respectively, of the study population.After 24 weeks, the mean changes in prebronchodilator and postbronchodilator FEV(1) were 180 mL (95% confidence interval [CI], approximately 91 to 268; p0.001) and 65 mL (95% CI, approximately 14 to 115; p = 0.012), respectively, greater for the SFC group than that for the placebo group. The differences in response to treatment were significant (all p0.0001) in former or current smokers but not in never-smokers (p0.05). The mean improvement in the total SGRQ score for the SFC group was 5.74 (p0.01) greater than that for the placebo group. SFC significantly reduced the frequency of nighttime awakenings and the use of relief bronchodilator. The adjusted ratio of exacerbations of COPD for the SFC group relative to the placebo group was 0.61 (95% CI, approximately 0.45 to 0.84; p0.01). There were no significant differences between the SFC and placebo groups in safety measures.SFC therapy achieved sustained improvement in lung function, quality of life, and control of symptoms, and was well tolerated in Chinese patients. Greater improvements in lung function were found only for COPD patients with a history of smoking.http://ctr.gsk.co.uk/Summary/fluticasone_salmeterol/studylist.asp Identifier: No. SCO100540.
Databáze: OpenAIRE
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