Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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]) (BETRI)

30 lipca 2026 zaktualizowane przez: Chiesi Farmaceutici S.p.A.

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

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

644

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Bułgaria
      • Rousse, Bułgaria, 7002
        • Rekrutacyjny
        • Medical Center Hermes Ruse LTD 12 Chavdar Voyvoda St.
        • Kontakt:
          • Nikolay Evgeniev Nikolaev

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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:

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: BDP/FF/GB
Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5 µg) - 2 inhalations bid
Lek: 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.
Inne nazwy:
  • Trimbow®
Aktywny komparator: BDP/FF
Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid
Lek: 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.
Inne nazwy:
  • Foster®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in ACQ-5 score
Ramy czasowe: 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).
Baseline to Month 12 (Visit 7)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in ACQ-5 at all applicable visits.
Ramy czasowe: 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).
Baseline to Month 12 (Visit 7)
Rate of severe asthma exacerbations
Ramy czasowe: 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.
Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
Rate of moderate/severe asthma exacerbations
Ramy czasowe: 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
Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
Time to first severe asthma exacerbation.
Ramy czasowe: Month 12 treatment period
Time to first severe asthma exacerbation.
Month 12 treatment period
Time to first moderate/severe asthma exacerbation.
Ramy czasowe: Month 12 treatment period
Time to first moderate/severe asthma exacerbation.
Month 12 treatment period
Speed of change questionnaire at each applicable study visit.
Ramy czasowe: Month 12 treatment period
Speed of change questionnaire at each applicable study visit.
Month 12 treatment period
Eosinophils value
Ramy czasowe: 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.
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)
Ramy czasowe: 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.
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
Ramy czasowe: 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)
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)
Asthma remission rate
Ramy czasowe: Month 6 (Visit 4), Month 12 (Visit 7)
Percentage of study participants with partial and complete asthma remission at 6 and 12 months.
Month 6 (Visit 4), Month 12 (Visit 7)
Change in Spirometry parameters: FEV1
Ramy czasowe: 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).
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 Spirometry parameters: FVC
Ramy czasowe: 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).
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 Spirometry parameters: FEV1/FVC ratio
Ramy czasowe: 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 (%).
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 Spirometry parameters: FEF25-75
Ramy czasowe: 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).
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 Spirometry parameters: ratio of FEF25-75 to FVC
Ramy czasowe: 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.
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 Spirometry parameters: FEV1%
Ramy czasowe: 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 (%).
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 Spirometry parameters: FVC% of predicted normal
Ramy czasowe: 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 (%).
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 Oscillometry parameters- R5 (Total airway resistance)
Ramy czasowe: 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.
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 Oscillometry parameters- R20 (Central airway resistance)
Ramy czasowe: 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.
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 Oscillometry parameters- R5-R20 (Peripheral airway resistance)
Ramy czasowe: 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.
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 Oscillometry parameters-X5 (Reactance)
Ramy czasowe: 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.
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 Oscillometry parameters-Fres (Resonant frequency)
Ramy czasowe: 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
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 Oscillometry parameters-AX (Area of reactance)
Ramy czasowe: 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.
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
Ramy czasowe: Month 12 treatment period
Number of days with oral systemic corticosteroids
Month 12 treatment period
Change from baseline in Test of Adherence to Inhalers (TAI) questionnaire at each applicable visit.
Ramy czasowe: 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.
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
Ramy czasowe: 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).
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 dose
Ramy czasowe: Month 12 treatment period
Dose of oral systemic corticosteroids (mg)
Month 12 treatment period

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Chiesi Farmaceutici S.p.A.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

28 czerwca 2026

Zakończenie podstawowe (Szacowany)

13 czerwca 2028

Ukończenie studiów (Szacowany)

13 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

21 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

24 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

31 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CLI-05993AB1-08
  • 2025-524289-56-00 (Ctis)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj