Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
Trial Parameters
Brief Summary
This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.
Eligibility Criteria
Inclusion Criteria: * Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years; * Non-smokers, ex-smokers; * Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive; * Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with: 1. low or medium doses of ICS (Inhaled Corticosteroids) alone; or 2. low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination). * Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score \<1.5 at screening and at randomisation. * Pre-BD (Bronchodilator) FEV1 \>40% and \<90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1). * A demonstrated increase in either FEV1 or forced vital capacity of \>12% and \>200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol