A 13 month, randomised, double-blind, parallel-group comparison of the efficacy of Seretide (fluticasone propionate/salmeterol combination Accuhaler) and Flixotide (fluticasone propionate Accuhaler) when down-titrating the inhaled corticosteroid dose in asthmatic adults who have previously received Seretide 500/50 ug twice daily for at least 4 weeks.

GlaxoSmithKline Australia Pty Ltd0 个研究点目标入组 70 人开始时间: 2005年9月23日最近更新: 2020年1月13日

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•Clinical diagnosis of asthma according to the American Thoracic Society for at least 6 months prior to enrolment; prior treatment with Seretide, either by Accuhaler or by MDI (with or without spacer), at a dose of 500/50 ug bd or 250/25 ug 2 inhalations bd, for a minimum of 4 weeks prior to enrolment; willing and able to comply with thetherapy and EDC requirements.Inclusion criteria for randomisation and entry into the down-titration period:Demonstrated ability to comply with the EDC requirements during run-in, plus evidence of adequate unsupervised spirometric technique; no moderate or severe exacerbation(s) in the past 4 weeks.

•Current smokers,subjects with a smoking history of >10 pack years or subjects who have given up smoking within 4 weeks prior to Visit 1; use of oral/parenteral or depot corticosteroids within 3 months prior to Visit 1; an acute asthma exacerbation requiring hospital admission within 3 months prior to Visit 1; a respiratory tract infection within the four weeks prior to Visit 1; other significant chronic respiratory disease; evidence of extrathoracic airway obstruction demonstrated by a plateau on the inspiratory flow volume loop at Visit 1; pregnant or lactating women.

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