This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.
The study will be conducted at sites in China. The study will be composed of a run-in period with CHF 1535 pMDI HFA-134a (reference product) followed by a 24-week randomised treatment period when CHF 5993 pMDI HFA-152a (test product) or the reference product will be administered. Total study duration is 27 weeks. AEs and SAEs will be monitored from the informed consent signature until the subject's study participation ends, including AEs of particular interest such as cough. Serial spirometry will be performed both for subjects under study treatment as well as for subjects that discontinued the study treatments but continued the study using a different medication
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
554
total daily dose of BDP/FF/GB:400/24/50 μg Administration: Two (2) inhalations twice daily(BID) (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF/GB: 400/24/50 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu AntiStaticTM to take the pMDI study treatments)
total daily dose of BDP/FF: 400/24 μg Administration: Two (2) inhalations BID (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF: 400/24 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu Anti-StaticTM to take the pMDI study treatments).
China-Japan Friendship Hospital
Beijing, Chaoyang District, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, Chaoyang District, China
RECRUITINGPeak FEV1
FEV1 = forced expiratory volume in the first second
Time frame: At week 24
Peak FEV1, FEV1, FEV1 area under curve(AUC)0-3h normalised by time
FEV1 = forced expiratory volume in the first second
Time frame: up to 24 weeks
PEF
PEF = peak expiratory flow
Time frame: at week 24
ACQ-7 score
The Asthma Control Questionnaire assesses asthma symptoms over last 7 days (night-time awakenings due to symptoms, morning symptoms, activity limitation, shortness of breath, wheezing), average daily rescue medication use, and current FEV1 percent predicted. Score scale: 0=totally controlled; 6=severely uncontrolled.
Time frame: up to 24 weeks
Average use of rescue medication
Average use of rescue medication
Time frame: at week 24
The number of moderate and severe exacerbations
The number of moderate and severe exacerbations
Time frame: at week 24
Time to first moderate or severe exacerbation
Time to first moderate or severe exacerbation
Time frame: at week 24
Average daily (morning and evening) asthma symptoms
Time frame: at week 24
Percentage of asthma control days
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Time frame: at week 24