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])

NCT07666490 | Recruiting Phase 4

• 2 other identifiers: CLI-05993AB1-082025-524289-56-00
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with a BDP/FF/GB 100/6/12.5 µg on asthma control outcomes relative to ICS/LABA therapy with BDP/FF 200/6 μg in a population with asthma poorly controlled.

Conditions

Asthma

Keywords

asthma control; adults; pragmatic study; BDP/FF/GB; BDP/FF

Outcome Measures

Primary Outcomes (1)

• Change in ACQ-5 score

  To demonstrate non inferiority of BDP/FF/GB-100/6/12.5 µg compared to 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. ACQ-5 is a one-week recall questionnaire including 5 patient-reported questions, each scored on a 7-point scale (0 = no impairment, 6 = maximum impairment). All questions are equally weighted, and the ACQ-5 score is calculated as the mean of the 5 responses, resulting in a total score ranging from 0 (totally controlled) to 6 (severely uncontrolled).

  Baseline to Month 12 (Visit 7)

Secondary Outcomes (27)

• Change from baseline in ACQ-5 at all applicable visits.

  Baseline to Month 12 (Visit 7)

• Rate of severe asthma exacerbations

  Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)

• Rate of moderate/severe asthma exacerbations

  Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)

• Time to first severe asthma exacerbation.

  Month 12 treatment period

• Time to first moderate/severe asthma exacerbation.

  Month 12 treatment period

Study Arms (2)

BDP/FF/GB

ACTIVE COMPARATOR

Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5 µg) - 2 inhalations bid

Drug: Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation)

BDP/FF

ACTIVE COMPARATOR

Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid

Drug: Foster® 200/6 pMDI (BDP/FF-200/6 µg)

Interventions

Foster® 200/6 pMDI (BDP/FF-200/6 µg) DRUG

Beclometasone dipropionate, formoterol fumarate (BDP/FF-200/6 µg) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months.

Also known as: Foster®

BDP/FF

Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation) DRUG

Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide BDP/FF/GB (100/6/12.5 µg per actuation) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months.

Also known as: Trimbow®

BDP/FF/GB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participant's written informed consent obtained prior to any study related procedure.
• \. Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.
• \. Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS/LABA regular treatment.
• \. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).
• \. 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.
• \. 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. ePRO completion) and the ability to understand the risks involved.
• Note: Study participants with asthma diagnosis and no clinically relevant concurrent COPD diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy (MART) can be included if the ICS dosage does not exceed 400 µg/day of beclometasone or equivalent.

You may not qualify if:

• Participation in another interventional clinical trial.
• Pregnant or breastfeeding women at the moment of enrolment.
• 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).
• Contraindication for LAMA use.
• Study participants on biological therapies for asthma.
• 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 (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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Medical Center Hermes Ruse LTD 12 Chavdar Voyvoda St.

Rousse, 7002, Bulgaria

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Formoterol Fumarate; Glycopyrrolate; Foster Home Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Clinical Trial INFO Chiesi Farmaceutici S.p.A.

CONTACT

+39 0521 2791; clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase IV, pragmatic, randomized, open-label, 2-arm parallel group, multi-center prospective study comparing BDP/FF/GB pMDI 100/6/12.5 µg BID with BDP/FF pMDI 200/6 μg BID in adults participants with asthma poorly controlled, using medium dose ICS/LABA for at least 3 months prior randomization.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 24, 2026
• Study Start: June 28, 2026
• Primary Completion (Estimated): June 13, 2028
• Study Completion (Estimated): June 13, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

BU (1)