This trial is not actively recruiting.
This trial has completed recruitment on this platform, and is no longer accepting new referrals.
A Phase 3, Double-Blind, Multicentre, Randomized, Active-Controlled, 2-Arm Parallel-Group Trial of CHF5993 in Subjects With Moderate to Severe Asthma
Why is the Study Being Conducted?
The purpose of this study is to evaluate the safety of CHF5993 pMDI 200/6/12.5 µg HFA-152a, compared to CHF5993 pMDI 200/6/12.5 µg HFA-134a, in subjects with asthma. CHF5993 has been developed with a sustainable propellant to help ease asthma symptoms by reducing inflammation and keeping the airways open. Investigators want to learn about any medical issues the participants might have after taking CHF5993 with either the HFA-134a or HFA-152a propellant, thereby contributing to a more comprehensive evaluation of the medications’ clinical safety and environmental impact.
TRECOS will also be investigating the environmental impacts of asthma medication propellants by testing the safety and efficacy of 2 types of inhalers (HFA-134a and HFA-152a) with the approved asthma medication, CHF5993. HFA-134a is a hydrofluorocarbon (HFC) propellant, currently a widely used asthma inhaler propellant, which negatively impacts air quality and contributes to rising greenhouse gas emissions. HFA-152a is a new propellant with significantly less global warming impact and is overall safer for the environment.
Estimated Enrollment
Approximately 513 Participants
Phase
Phase 3Eligibility Criteria
Participants must:
Inclusion Criteria
Participants must
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Be male or female, aged > 18 and < 75 years old.
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Have physician-diagnosed asthma for at least 6 months and with diagnosis before the age of 50 years.
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Be on a stable asthma treatment with medium/high doses of inhaled corticosteroids (ICS) + long acting β-agonist (LABA) + long-acting muscarinic antagonist (LAMA) or medium/high doses of ICS+LABA for at least 4 weeks before screening.
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Non-smokers or ex-smokers who smoked <10 pack-years and stopped smoking > 1 years (6 months for e-cigarettes) prior to screening.
Participants must not:
Exclusion Criteria
Participants must not
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Have history of near fatal asthma, hospitalization for asthma in ICU, emergency room access for asthma in the previous 6 months before enrollment
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Have history of asthma exacerbation requiring SCS or emergency room admission/hospitalisation within 4 weeks prior to the study entry and/or during run in period
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Have non-permanent asthma not requiring daily asthma control medicine
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Any concomitant respiratory disease which can include but is not limited to: COPD, known alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, pulmonary hypertension, and interstitial lung disease/pulmonary fibrosis
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History of lobectomy, pneumonectomy, or other sizeable lung volume resection (total volume of lung removed > 25%)
About the Study
TRECOS is a 12-week, a 12-week double-blind, multicentre, randomised, active-controlled, 2-arm, parallel-group clinical trial to evaluate the safety of CHF5993 (Trimbow) pMDI 200/6/12.5 µg HFA-152a, compared to CHF5993 pMDI 200/6/12.5 µg HFA-134a, in subjects with asthma.
We would like to ask you for your help in referring any patients who may be eligible, with their permission. Please feel free to discuss any information about the TRECOS study with your patient first.
What Will Happen in This Trial
In total, the participants will have 7 visits (6 on-site and 1 via call) over a period of 16 weeks.
Travel Support
The sponsor will reimburse patients all reasonable costs they may have due to study participation (e.g. travel to the Study Centre visits).
More details about this will be explained by the trial site and included in your informed consent form.
Your patient may ask site staff about travel support and other support offered for this trial.
Study locations
Click here to see the full list of eligibility criteria.
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