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

Completed · Phase 3

Conditions studied: Asthma

In brief

Compare the superiority of CHF 1535 versus CHF 718 in subjects with asthma who are on medium or high dose inhaled corticosteroids.

Key facts

Study ID: NCT05292586
Run by: Chiesi Farmaceutici S.p.A.
People needed: 1377
Starts: 2022-08-31
Expected to finish: 2024-06-24
Last updated by the study team: 2026-07-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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.
Smoking status: Current smokers or ex-smokers with total cumulative exposure equal to or more than 10 pack-years or having stopped smoking within one year prior to screening visit.
E-cigarette status: Current e-cigarettes users at the time of the screening visit.
Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana).
Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening.
Cardiovascular diseases: Subjects who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to screening, not controlled with a rate control strategy. Note: Subjects with Permanent Atrial Fibrillation (for at least 6 months) with a resting ventricular rate <100/min, controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin, or ablation therapy) can be considered for the enrollment.
ECG criteria: An abnormal and clinically significant 12-lead electrocardiogram (ECG) which may impact the safety of the subject according to Investigator's judgement. In terms of the QTcF, subjects with QTcF >450ms for males or QTcF >470ms for females at screening or at randomization visits (criterion not applicable for subject with pacemaker or permanent atrial fibrillation).
Other medical conditions: Other active severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Vaccination: Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
Subjects' wellbeing: Subjects mentally or legally incapacitated, including but not limited to subjects who are institutionalized or incarcerated.
Hypersensitivity: Subjects with known intolerance, hypersensitivity or contraindication to treatment with ß2-agonists, ICS, or propellant gases/excipients.
Surgery: Subjects with major surgery in the 3 months prior to the screening visit or planned surgery during the study.
Additional treatment: Subjects treated with non-potassium sparing diuretics (unless administered as a fixed-dose combination with a potassium conserving drug or changed to potassium sparing before the screening), non-selective beta-blocking drugs, quinidine, quinidine-like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation.
Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-immunoglobulin E (IgE), anti-IL5 or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
Subjects who are receiving any therapy that could interfere with the study drugs according to investigator's opinion.
Participating in other investigational trial: Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
Spacer: The need to use a spacer for correct self-administration of a pMDI.

Where it is running

Chiesi Clinical Trial Site 840895 — Chandler, Arizona, United States
Chiesi Clinical Trial Site 840856 — Encinitas, California, United States
Chiesi Clinical Trial Site 840843 — Huntington Beach, California, United States
Chiesi Clinical Trial Site 840860 — Huntington Beach, California, United States
Chiesi Clinical Trial Site 840896 — Long Beach, California, United States
Chiesi Clinical Trial Site 840883 — Los Angeles, California, United States
Chiesi Clinical Trial Site 840810 — Los Angeles, California, United States
Chiesi Clinical Trial Site 840869 — Newport Beach, California, United States
Chiesi Clinical Trial Site 840890 — North Hollywood, California, United States
Chiesi Clinical Trial Site 840808 — Northridge, California, United States
Chiesi Clinical Trial Site 840879 — Pomona, California, United States
Chiesi Clinical Trial Site 840868 — Sacramento, California, United States
Chiesi Clinical Trial Site 840849 — San Diego, California, United States
Chiesi Clinical Trial Site 840877 — San Diego, California, United States
Chiesi Clinical Trial Site 840861 — San Jose, California, United States
Chiesi Clinical Trial Site 840881 — Westminster, California, United States
Chiesi Clinical Trial Site 840873 — Colorado Springs, Colorado, United States
Chiesi Clinical Trial Site 840800 — Denver, Colorado, United States
Chiesi Clinical Trial Site 840820 — Coral Gables, Florida, United States
Chiesi Clinical Trial Site 840841 — Cutler Bay, Florida, United States
Chiesi Clinical Trial Site 840817 — Greenacres City, Florida, United States
Chiesi Clinical Trial Site 840822 — Hialeah, Florida, United States
Chiesi Clinical Trial Site 840838 — Hialeah, Florida, United States
Chiesi Clinical Trial Site 840864 — Kissimmee, Florida, United States
Chiesi Clinical Trial Site 840858 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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