Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists

ConditionAsthma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChiesi Farmaceutici S.p.A.

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

Treatment groups

554 Participants
are divided into 2 treatment groups

Sponsors and collaborators