assess the efficacy and safety of Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) in combination with seretide to patients with Asthma. a randomized, double-blind, double-dummy, positive-controlled, parallel-group trail.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
50ug/250ug 1 puff twice a day for 4 weeks
50ug/250ug 1 puff twice a day for 4 weeks
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGChange from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28
Time frame: 28 days
Change from baseline (visit 2) in Forced vital capacity (FVC) on day 28
Time frame: 28 days
FEV1~AUC0-12h
The Forced expiratory volume in 1 second of area under the curve from 0h to 12h on day 1
Time frame: 12 hours
PEF
The mean of morning and night peak expiratory flow
Time frame: 28 days
The mean of morning and night Asthma symptom scores
the outcomes are respectively: Day-1\~day-7,Day1\~day7,Day8\~day14,Day15\~day21,Day22\~day28
Time frame: up to 28 days
The mean of peak expiratory flow (PEF)variation of morning and night
Time frame: up to 28 days
Use of ventolin during the treatment
Time frame: 28 days
Number of asthma acute exacerbations with subjects
Time frame: 28 days
Subject self- questionare at visit 4
questionare respectively have significant effectiveness , effectiveness ,Invalid , Deterioration
Time frame: 28 days
Questionnaire of Asthma control test scores
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
25 score reprent Partially controlled;20-25 score represent fully controlled;\<20 score represent not controlled
Time frame: 28 days