Therapeutic equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in subjects with mild to moderate asthma (TRECONY)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Chiesi Farmaceutici S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

13 Apr 2026 → ongoing

Decision date (initial)

2026-03-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Chiesi Farmaceutici S.p.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

To demonstrate the therapeutic equivalence of CHF5993 pMDI HFA-152a versus (vs.) CHF5993 pMDI HFA-134a in terms of change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (h) (AUC0-4h) on Day 1 and in pre-dose FEV1 on Day 28 in adults with mild to moderate, controlled/partly controlled asthma

Secondary objectives 1

1. To evaluate the safety and tolerability profile of the study treatments in adults with mild to moderate, controlled/partly controlled asthma

Conditions and MedDRA coding

Mild to moderate asthma

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. 1. Informed consent: obtained prior to any study-related procedure
2. 2. Sex and age: male and female adults aged ≥18 and ≤75 years
3. 3. Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive
4. 4. Smoking status: non-smokers or ex-smokers who smoked ≤10 pack-years prior to screening
5. 5. Diagnosis of asthma: documented physician-diagnosed asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years
6. 6. Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with: a.low or medium doses of ICS alone; or b.low or medium doses of ICS + LABA (fixed or free combination). Low and medium doses of ICS are defined as non-extrafine BDP 200-500 μg and >500-1000 μg respectively, or estimated clinically comparable dose per the Global Initiative for Asthma 2024
7. 7. Asthma control: controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score <1.5 at screening and at randomisation
8. 8. Lung function: pre-BD FEV1 >40% and <90% of the predicted normal value, after appropriate wash-out from BDs, at the Screening Visit (V1)
9. 9. Bronchodilator responsiveness: 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)
10. 10. Rescue medication: subjects must be able to replace their current rescue medication with a salbutamol (i.e. albuterol) inhaler for use as needed for the duration of the study
11. 11. Current therapy: subjects must be able to safely discontinue their asthma medications (ICS with or without LABA) during the run-in period and for the remainder of the study
12. 12. Spacer non-use: subjects must be able to inhale the study treatment without using a spacer
13. 13. Subjects must have a willingness and ability to: a. Be trained to correctly use the pMDI inhalers and the electronic diary (e-Diary); b. Read/write; c. Perform all study-related procedures, including technically acceptable spirometry and e-Diary completion; d. Understand the risks involved
14. 14. Female subjects: a. Woman of childbearing potential (WOCBP) using a highly effective birth control method (refer to protocol for more details) or b. Women of non-childbearing potential

Exclusion criteria 24

1. 1. History of high-risk asthma: 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
2. 2. Recent asthma exacerbation: 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 (to be checked again at randomisation)
3. 3. Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
4. 4. Asthma subjects currently treated with any of the following: a. High dose ICS; b. Long-acting muscarinic antagonist (LAMA); c. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening; d. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening; e. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening
5. 5. Respiratory disorders other than asthma: any concomitant respiratory disorder other than asthma that, in the opinion of the Investigator and/or Medical Monitor, will interfere with the evaluation of the investigational medicinal product (IMP) or interpretation of subject safety or study results
6. 6. Lung resection: subjects with a history of lobectomy, pneumonectomy or other sizable lung volume resection (total volume of lung removed >25%)
7. 7. Lower respiratory tract infection: subjects with lower respiratory tract infection that required use of antibiotics, if unresolved within 4 weeks prior to screening or if occurring during the run-in period (to be re-checked at randomisation)
8. 8. Lung cancer and history of lung cancer: subjects with and active diagnosis of lung cancer or a history of lung cancer
9. 9. Subjects with active cancer or a history of cancer (other than lungs) with less than 5 years disease-free survival time (whether or not there is evidence of local recurrence or metastases). Localised carcinoma (e.g. basal cell carcinoma, in situ carcinoma of the cervix adequately treated) is acceptable
10. 10. Electrocardiogram (ECG) criteria: any clinically significant abnormal 12-lead ECG that, in the Investigator’s opinion, would affect efficacy or safety evaluations or place the subjects at risk
11. 11. ECG QTcF: male subjects with a QT interval corrected using Fridericia’s formula (QTcF) >450 milliseconds (ms) and female subjects with a QTcF >470 ms at Screening Visit (V1) are not eligible
12. 12. Other medical conditions: previous medical history, evidence of an uncontrolled, severe, intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis
13. 13. Concurrent diseases: subjects with a medical history or current diagnosis of narrow-angle glaucoma, symptomatic prostatic hypertrophy, urinary retention, or bladder neck obstruction that, in the opinion of the Investigator, would prevent the use of anticholinergic agents
14. 14. Subjects receiving non-selective β2-blockers, quinidine and quinidine-like anti-arrhythmics, tricyclic anti-depressants, monoamine oxidase inhibitors, cytochrome P450 3A4 inhibitors and non-potassium sparing diuretics within 4 weeks prior to screening (unless the diuretic is administered as a fixed-dose combination with a potassium-conserving drug)
15. 15. Contra-indications to IMPs. For warnings, eligibility will be judged by the Investigator
16. 16. History of hypersensitivity to any components of the study treatments or a history of other allergies that, in the opinion of the Investigator, contraindicates the subject’s participation
17. 17. Non-permitted concomitant medications: subjects receiving treatment with one or more drugs listed in the non-permitted concomitant medications section
18. 18. Clinical evidence of candidiasis at the oropharyngeal examination at screening or randomisation (to be re-checked at randomisation)
19. 19. Documented coronavirus disease 2019 (COVID-19) diagnosis within 2 weeks prior to screening, or associated complications/symptoms, which have not resolved within 14 days prior to screening (to be re-checked at randomisation)
20. 20. Alcohol/drug abuse: subjects with a known or suspected history of alcohol and/or substance/drug abuse within 12 months prior to screening (to be re-checked at randomisation)
21. 21. Participation in other investigational studies: subjects who have received any investigational drug within the 30 days (60 days for biologics) or approximately 5 half-lives of the investigational drug (whichever is longer) prior to screening, or who have been previously randomized in this study, or who are currently participating in another clinical study (to be re-checked at randomisation)
22. 22. Pregnant or lactating women
23. 23. Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation
24. 24. Vaccination: subjects having received a vaccination within 2 weeks prior to screening or during the run-in period (to be rechecked at randomisation)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Change from baseline in FEV1 AUC0-4h on Day 1 • Change from baseline in pre-dose FEV1 on Day 28

Secondary endpoints 6

1. Relative and absolute change from pre-dose FEV1 at all post-dose timepoints at each visit
2. Number and percentage of subjects with a >15% relative decrease from pre-dose in FEV1 at any post-dose timepoint at each visit
3. Change from pre-dose FEV1 area under the curve from time 0 to 2 h (AUC0-2h) on Day 28
4. Change from baseline (Day 1) in ACQ-7 scores on Day 28
5. Average daily use of rescue medication (number of puffs/day), percentage of days without intake of rescue medication and percentage of asthma control days during the TP
6. Average morning and evening PEF and average daily symptoms during TP

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Chiesi Farmaceutici S.p.A.

Sponsor organisation

Chiesi Farmaceutici S.p.A.

Address

Via Palermo 26/a

City

Parma

Postcode

43122

Country

Italy

Scientific contact point

Organisation

Chiesi Farmaceutici S.p.A.

Contact name

Clinical Project Manager

Public contact point

Organisation

Chiesi Farmaceutici S.p.A.

Contact name

Clinical Project Manager

Third parties 8

Locations

10 EU/EEA countries · 112 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 131 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications