AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma

RecruitingPhase 2Ages 18 Years - 75 YearsAllChiesi Farmaceutici S.p.A.
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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) pMDI at the Screening Visit (V1). Exclusion Criteria: * History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk; * Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period ; * Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine; * Asthma subjects currently treated with any of the following : 1. High dose ICS; 2. Long-acting muscarinic antagonist (LAMA); 3. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening; 4. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening; 5. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening; * Respiratory disorders other than asthma * Lung resection; * Lower respiratory tract infection; * Lung cancer and history of lung cancer; * Subjects with active cancer or a history of cancer (other than lungs) ; * Patients who have clinically significant cardiovascular condition; * Run-in compliance: e-Diary completion \<75% and run-in treatment compliance \<75% at randomisation;
💊

What it tests

  • CHF5993 pMDI with HFA-152a
  • CHF5993 pMDI with HFA-134a
  • CHF718 pMDI with HFA-134a
📍

Where

167 sites
Hospital Británico de Buenos Aires_Site n. 032029
Buenos Aires, Argentina
Centro Medico de Enfermedades Respiratorias_Site n. 032002
Buenos Aires, Argentina
Centro Medico Respire_Site n. 032014
Buenos Aires, Argentina
Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018
Buenos Aires, Argentina
Centro de Investigaciones Médicas Mar del Plata_Site n. 032019
Buenos Aires, Argentina
Fundacion CIDEA_Site n. 032009
Buenos Aires, Argentina
Centro Medico Arsema_Site n. 032003
Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)_Site n. 032025
Ciudad Autonoma de Buenos Aire, Argentina

…and 159 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy