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New treatment option for Asthma
Official title Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
ClinicalTrials.gov ID: NCT07301736
What this study is testing
What is CHF5993 pMDI with HFA-152a?
CHF5993 pMDI with HFA-152a is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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:
- low or medium doses of ICS (Inhaled Corticosteroids) alone; or
You likely can't join if
- History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the...
- Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to...
- Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;
- Asthma people currently treated with any of the following :
- High dose ICS;
- Long-acting muscarinic antagonist (LAMA);
See the full eligibility 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:
- low or medium doses of ICS (Inhaled Corticosteroids) alone; or
- 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).
- 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...
- 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 people currently treated with any of the following :
- High dose ICS;
- Long-acting muscarinic antagonist (LAMA);
- Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
- Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
- 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;
- people 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;
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Argentina
- Ciudad Autonoma de Buenos Aire, Argentina
- Córdoba, Argentina
- La Plata, Argentina
- Mendoza, Argentina
- Quilmes, Argentina
- Rosario, Argentina
- San Juan Bautista, Argentina
- San Miguel de Tucumán, Argentina
- Santa Fe, Argentina
- Banja Luka, Bosnia and Herzegovina
- Doboj, Bosnia and Herzegovina
- Sarajevo, Bosnia and Herzegovina
- Siroki Brijeg, Bosnia and Herzegovina
- Tešanj, Bosnia and Herzegovina
- Tuzla, Bosnia and Herzegovina
- Gorna Oryahovitsa, Bulgaria
- Haskovo, Bulgaria
- Kozloduy, Bulgaria
- Lovech, Bulgaria
+ 85 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Argentina; Ciudad Autonoma de Buenos Aire, Argentina; Córdoba, Argentina; La Plata, Argentina; Mendoza, Argentina; Quilmes, Argentina and 99 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.