ClinicaliQ Trial Snapshot
- Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT07301736.
- What is being tested: Therapeutic equivalence of CHF5993 pMDI (a combination inhaler containing beclomethasone/formoterol/glycopyrronium) formulated with HFA-152a propellant versus the standard formulation, to confirm the new environmentally-friendly propellant delivers equivalent clinical efficacy and safety.
- Patient eligibility overview: Adults with mild to moderate asthma who have documented disease stability and baseline lung function meeting defined criteria; likely excluding patients with severe asthma, significant comorbidities, or recent exacerbations.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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 40% and 12% and >200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1).
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.