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.
Subjects must provide written informed consent prior to any study-related procedures;
Subjects must be male or female Chinese aged ≥18 and
Subjects must have a documented history of asthma for at least 1 year and asthma must have been diagnosed before the subject's age of 40;
Subjects must have uncontrolled asthma, receiving double therapy only on medium doses of ICS in combination with LABA at a stable dose for at least 4 weeks prior to screening;
Subjects who have a history of near fatal asthma or of a past hospitalisation for status asthmaticus or severe asthma exacerbation which, in the judgement of the Investigator, may place the subject at undue risk;
Subjects who have undergone hospitalisation, emergency room visit or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to the screening visit or during the run-in period;
Subjects with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period;
Subjects with any change in dose, schedule or formulation of the combination ICS+LABA in the 4 weeks prior to the screening visit;
Parallel
Experimental: Participant Group CHF 5993 pMDI HFA-152a
Drugtotal 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)
Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a
Other interventiontotal 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).
Peak FEV1
FEV1 = forced expiratory volume in the first second
Peak FEV1, FEV1, FEV1 area under curve(AUC)0-3h normalised by time
FEV1 = forced expiratory volume in the first second
PEF
PEF = peak expiratory flow
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.
Average use of rescue medication
Average use of rescue medication
Click on the lead sponsor to view all of their trials.
