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NCT Number: NCT07666490

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])

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Center Hermes Ruse LTD 12 Chavdar Voyvoda St.

Rousse, 7002, Bulgaria

Location status: Recruiting

Location contact

Nikolay Evgeniev Nikolaev

CONTACT

About this study

This is a phase IV, pragmatic, randomized, open-label, 2-arm parallel group, multi-center. The study aims to compare BDP/FF/GB pMDI 100/6/12.5 µg BID with BDP/FF pMDI 200/6 μg BID in adult participants with asthma poorly controlled, using medium dose ICS/LABA for at least 3 months prior randomization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1 . 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.

Exclusion criteria

The presence of any of the following will exclude a study participant from study enrolment:

  • 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.

Treatment and study plan

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.

Other names: Trimbow®

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.

Other names: Foster®

Primary outcomes

  1. Change in ACQ-5 score

    Time frame: Baseline to Month 12 (Visit 7)

    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).

Secondary outcomes

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

    Time frame: Baseline to Month 12 (Visit 7)

    Change from baseline in ACQ-5 at all applicable visits. Asthma Control Questionnaire-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).

  2. Rate of severe asthma exacerbations

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

    Rate of severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months.

  3. Rate of moderate/severe asthma exacerbations

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

    Rate of moderate/severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months

  4. Time to first severe asthma exacerbation.

    Time frame: Month 12 treatment period

    Time to first severe asthma exacerbation.

  5. Time to first moderate/severe asthma exacerbation.

    Time frame: Month 12 treatment period

    Time to first moderate/severe asthma exacerbation.

  6. Speed of change questionnaire at each applicable study visit.

    Time frame: Month 12 treatment period

    Speed of change questionnaire at each applicable study visit.

  7. Eosinophils value

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Change from baseline in eosinophils value at each applicable study visit.

  8. Oral systemic corticosteroids days

    Time frame: Month 12 treatment period

    Number of days with oral systemic corticosteroids

  9. Change from baseline in Test of Adherence to Inhalers (TAI) questionnaire at each applicable visit.

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Test of Adherence to Inhalers (TAI) questionnaire change. The TAI-10 score is automatically calculated on the electronic device by summing the individual item scores (1-10) ranging from 10-50, with higher score indicating better adherence. The TAI 12-item total score is derived manually as sum of TAI-10 total score and items 11 and 12 scores.

  10. Change in quality-of-life questionnaire: EQ-5D-5L

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    EQ-5D-5L = EuroQol 5-Dimension 5-Level: index values range from <0 to 1 (higher values indicate better health), and EQ VAS scores range from 0 to 100 (higher scores indicate better self-rated health).

  11. Change in Chronic Airways Assessment Test (CAAT)

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    CAAT questionnaire consists of 8 items scored from 0 to 5, with a total score ranging from 0 to 40; higher scores indicate worse health status.

  12. Cardiovascular Event Rate

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Percentage of study participants with cardiovascular and/or fatal events (considering standard adverse event [AE] data collection)

  13. Asthma remission rate

    Time frame: Month 6 (Visit 4), Month 12 (Visit 7)

    Percentage of study participants with partial and complete asthma remission at 6 and 12 months.

  14. Change in Spirometry parameters: FEV1

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by spirometry: FEV1 (forced expiratory volume in 1 second), expressed as volume (L).

  15. Change in Spirometry parameters: FVC

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by spirometry: FVC (forced vital capacity), expressed as volume (L).

  16. Change in Spirometry parameters: FEV1/FVC ratio

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by spirometry: FEV1/FVC ratio, expressed as a percentage (%).

  17. Change in Spirometry parameters: FEF25-75

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by spirometry: FEF25-75 (forced expiratory flow between 25% and 75% of FVC), expressed as flow (L/s).

  18. Change in Spirometry parameters: ratio of FEF25-75 to FVC

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by spirometry: ratio of FEF25-75 to FVC.

  19. Change in Spirometry parameters: FEV1%

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by spirometry: FEV1 as percentage of predicted normal values (%).

  20. Change in Spirometry parameters: FVC% of predicted normal

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by spirometry: FVC as percentage of predicted normal values (%).

  21. Change in Oscillometry parameters- R5 (Total airway resistance)

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by oscillometry: Resistance at 5 Hz (R5), representing total airway resistance, expressed in kPa·L-¹·s.

  22. Change in Oscillometry parameters- R20 (Central airway resistance)

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by oscillometry: Resistance at 20 Hz (R20), representing central airway resistance, expressed in kPa·L-¹·s.

  23. Change in Oscillometry parameters- R5-R20 (Peripheral airway resistance)

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by oscillometry: Difference between resistance at 5 Hz and 20 Hz (R5-R20), representing peripheral airway resistance, expressed in kPa·L-¹·s.

  24. Change in Oscillometry parameters-X5 (Reactance)

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by oscillometry: Reactance at 5 Hz (X5), reflecting distal airway reactance, expressed in kPa·L-¹·s.

  25. Change in Oscillometry parameters-Fres (Resonant frequency)

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by oscillometry: Resonant frequency (Fres), defined as the frequency at which reactance equals zero, expressed in Hz

  26. Change in Oscillometry parameters-AX (Area of reactance)

    Time frame: Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)

    Pulmonary function tests measured by oscillometry: Area of reactance (AX), representing the integrated low-frequency reactance, expressed in Hz·kPa·L-¹·s.

  27. Oral systemic corticosteroids dose

    Time frame: Month 12 treatment period

    Dose of oral systemic corticosteroids (mg)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial INFO Chiesi Farmaceutici S.p.A.

CONTACT

[email protected]

+39 0521 2791

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

A Pragmatic, Phase IV, Randomized, Open-label, Multinational, Multicentre, 2-arm Parallel Group, Prospective Study Comparing Efficacy and Safety of Single Inhaler ICS/LABA/LAMA (Beclometasone/Formoterol Fumarate/Glycopyrronium Bromide [87/5/9 pMDI { BD/FF/GB -100/6/12.5 μg} ]) vs Single Inhaler ICS/LABA (Beclometasone Dipropionate Plus Formoterol Fumarate [200/6 pMDI { BD/FF - 200/6 μg} ]) in Asthma Subjects

Acronym: BETRI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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