A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 … (NCT05292586) | Clinical Trial Compass
CompletedPhase 3
A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid
United States1,377 participantsStarted 2022-08-31
Plain-language summary
Compare the superiority of CHF 1535 versus CHF 718 in subjects with asthma who are on medium or high dose inhaled corticosteroids.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed consent: A signed and dated written informed consent obtained prior to any study-related procedures.
. Sex and age: Male or female aged ≥18 and ≤75 years.
. Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40
. Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-dose ICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening).
. Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators, at the screening and randomization visits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening.
. Reversibility post-bronchodilator: Subjects with a positive reversibility to bronchodilator at screening, defined as an increase in FEV1 \> 12% and \> 200mL compared to baseline within 30 minutes after 4 inhalations of albuterol hydrofluoroalkane (HFA) pMDI 90µg/actuation.
. Female subjects:
. Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared CHF 1535 pMDI, which combines a corticosteroid with a bronchodilator, against CHF 718 pMDI, which is a corticosteroid alone — given that I'm currently on a medium or high-dose inhaled corticosteroid, could adding a bronchodilator component like in CHF 1535 be a meaningful next step for my asthma management?
2The trial measured lung function improvement specifically over a 12-week period using a test called FEV1 — do you think 12 weeks is enough time to judge whether a new inhaler is working well for someone with my asthma history?
3Since this was a Phase 3 trial that has now completed, does that mean results are available, and if so, what did they show about whether CHF 1535 actually performed better than the corticosteroid-only inhaler?
4Given that this study enrolled adults already on medium or high-dose inhaled corticosteroids, does my current level of asthma control suggest I might benefit from a combination inhaler approach, or is there a reason to try other adjustments to my current regimen first?
5Since the trial is completed but I'm still managing my asthma, are there approved combination inhalers similar to what was tested in this study that my care team could consider for me right now, rather than waiting for any further research?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 12
Timeframe: Baseline (pre-dose on Week 0) and Week 12.
. Pregnancy or lactation: where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive pregnancy test (serum and urine pregnancy test to be performed at screening visit and urine pregnancy test to be performed prior to randomization).
. Poor compliance with run-in medication or eDiary completion \<50% before randomization.
. History of "at risk" asthma: History of near-fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the investigator, may place the subject at undue risk.
. Recent asthma exacerbation: Hospitalization, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to screening visit or during the run-in period.
. Unresolved respiratory tract infection (RTI) in the 4 weeks prior to the screening visit or during run-in period. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks or complications from this disease, which have not resolved within 14 days prior to screening.
. Unstable ICS dose during the 4 weeks prior to screening visit, including any change in dose, schedule, or formulation.
. Use of systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks before screening.
. Respiratory disorders other than asthma: History of a diagnosis of cystic fibrosis, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), (as defined by the current Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Report), alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.