BETRI-Prospective: Asthma control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 µg]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 µg])

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]

Decision date (initial)

2026-05-20

Transition trial

No

Low-intervention

Yes

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Chiesi Farmaceutici S.p.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To demonstrate noninferiority of Trimbow® 87/5/9 pMDI (BDP/FF/GB-100/6/12.5 µg) compared to Foster® 200/6 pMDI (BDP/FF-200/6 µg) in terms of change in the Asthma Control Questionnaire-5 (ACQ-5) at Visit 7 (i.e. at Month 12) versus baseline.

Secondary objectives 2

1. 1.To assess long-term safety and tolerability of Trimbow® 87/5/9 pMDI (BDP/FF/GB-100/6/12.5 µg) compared to Foster® 200/6 pMDI (BDP/FF-200/6 µg).
2. 2. To evaluate the effect of Trimbow® 87/5/9 pMDI (BDP/FF/GB-100/6/12.5 µg) compared to Foster® 200/6 pMDI (BDP/FF-200/6 µg) in other lung function parameters, asthma exacerbations, study participants’ health status, and clinical outcome measures.

Conditions and MedDRA coding

Asthma

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Study participant’s written informed consent obtained prior to any study related procedure.
2. 2. Male or female study participants aged ≥18 years old.
3. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.
4. 4. Stable asthma treatment prior randomisation: At least 3 months on any MS ICS/LABA regular treatment.
5. 5. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).
6. 6. Women with childbearing potential (WOCBP) and with fertile male partners :they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the last visit.
7. 7. Study participants must have a cooperative attitude and the ability to be trained to use the patient app correctly, to be able to perform the required outcomes measurements (e.g. electronic patient-reported outcome [ePRO] completion) and the ability to understand the risks involved. Note: Study participants with asthma diagnosis and no clinically relevant concurrent chronic obstructive pulmonary disease diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy can be included if the ICS dosage does not exceed 400 µg/day of beclometasone or equivalent.

Exclusion criteria 6

1. 1. Participation in another interventional clinical trial.
2. 2. Pregnant or breastfeeding women at the moment of enrolment.
3. 3. Other chronic respiratory disease: Lung Cancer, known alpha1-antitrypsin deficiency, active tuberculosis, clinically significant bronchiectasis, interstitial lung disease, pulmonary hypertension, or any other uncontrolled/clinically significant diseases (according to investigator’s judgement).
4. 4. Contraindication for long-acting muscarinic antagonists use.
5. 5. Study participants on biological therapies for asthma.
6. 6. For France only: Individuals under court protection (including protected adults) and individuals not affiliated to a social security system are excluded from participation in this study, as detailed in Appendix 4 (Country/Region-Specific Differences – France), in accordance with Articles L.1121‑6, L.1121‑8, and L.1121‑8‑1 of the French Public Health Code.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Change from baseline in ACQ-5 at Visit 7

Secondary endpoints 17

1. 1. Change from baseline in ACQ-5 at all applicable visits.
2. 2. Rate of severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months.
3. 3. Rate of moderate/severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months.
4. 4. Time-to-first severe asthma exacerbation.
5. 5. Time-to-first moderate/severe asthma exacerbation.
6. 6. Speed of change questionnaire at each applicable study visit.
7. 7. Change from baseline in eosinophils value at each applicable study visit.
8. 8. Number of days and total dose with oral systemic corticosteroids during the 12-month treatment period.
9. 9. Change from baseline in Test of the Adherence to Inhalers questionnaire at each applicable visit.
10. 10. Change from baseline in spirometry parameters at each applicable on-site visit.
11. 11. Change from baseline in oscillometry parameters at each applicable on-site visit.
12. 12. Change from baseline in quality of life questionnaire (EuroQol 5-Dimension 5-Level questionnaire; EQ-5D-5L) at each applicable visit.
13. 13. Change from baseline in chronic airways assessment test questionnaire at each applicable visit.
14. 14. Percentage of study participants with cardiovascular and/or fatal events (considering standard adverse event [AE] data collection).
15. 15. Percentage of study participants with Asthma Remission (Partial** and Complete Remission*) at 6 and 12 months.
16. 15. *Complete Clinical Asthma Remission is defined as: a) No systemic corticosteroid intake at the timepoint (i.e. 6 or 12 months). b) No severe asthma exacerbation occurrence before the timepoint (i.e. 6 or 12 months). c) ACQ-5 ≤1.5 at the timepoint (i.e. 6 or 12 months). d) Change from baseline (i.e. Visit 1) in predose (12 hours from last administration) forced expiratory volume in 1 second at the timepoint (i.e. 6 or 12 months ≥0 mL).
17. 15. ** Partial Clinical Asthma Remission is defined as: -No systemic corticosteroid intake at the timepoint (i.e. 6 or 12 months). -Two of the other 3 criteria are met (b, c, d).

Investigational products

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

Test 1

Comparator 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 3

Locations

9 EU/EEA countries · 91 investigational sites

By country

Investigational sites

Results and documents

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

Documents 114 files

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

Application history

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