About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Experimental: Participant Group CHF 5993 pMDI HFA-152a
- Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a