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Recruiting 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])

Phase IV Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation), Foster® 200/6 pMDI (BDP/FF-200/6 µg).
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bulgaria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

Interventions

  • Drug Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation)
    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.
  • Drug Foster® 200/6 pMDI (BDP/FF-200/6 µg)
    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.

Primary outcome measures

  • Change in ACQ-5 score [Time frame: Baseline to Month 12 (Visit 7)]
Secondary outcome measures (12)
  • Change from baseline in ACQ-5 at all applicable visits. [Time frame: Baseline to Month 12 (Visit 7)]
  • 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 moderate/severe asthma exacerbations [Time frame: Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)]
  • Time to first severe asthma exacerbation. [Time frame: Month 12 treatment period]
  • Time to first moderate/severe asthma exacerbation. [Time frame: Month 12 treatment period]
  • Speed of change questionnaire at each applicable study visit. [Time frame: Month 12 treatment period]
  • 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)]
  • Oral systemic corticosteroids days [Time frame: Month 12 treatment period]
  • 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)]
  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

Inclusion criteria

1 . Study participant's written informed consent obtained prior to any study related procedure.

2\. Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.

4\. Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS/LABA regular treatment.

5\. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).

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\. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Bulgaria · 1 center
  • Medical Center Hermes Ruse LTD 12 Chavdar Voyvoda St. — Rousse

Identifiers

NCT: NCT07666490 · CLI-05993AB1-08 · 2025-524289-56-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗