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.
This trial is not recruiting at the moment. You can still explore other options:
