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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. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

644

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: BDP/FF/GB
Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5 µg) - 2 inhalations bid
Arzneimittel: 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.
Andere Namen:
  • Trimbow®
Aktiver Komparator: BDP/FF
Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid
Arzneimittel: 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.
Andere Namen:
  • Foster®

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in ACQ-5 score
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in ACQ-5 at all applicable visits.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: Month 12 treatment period
Time to first severe asthma exacerbation.
Month 12 treatment period
Time to first moderate/severe asthma exacerbation.
Zeitfenster: Month 12 treatment period
Time to first moderate/severe asthma exacerbation.
Month 12 treatment period
Speed of change questionnaire at each applicable study visit.
Zeitfenster: Month 12 treatment period
Speed of change questionnaire at each applicable study visit.
Month 12 treatment period
Eosinophils value
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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%
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Month 12 treatment period
Dose of oral systemic corticosteroids (mg)
Month 12 treatment period

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chiesi Farmaceutici S.p.A.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. Juni 2026

Primärer Abschluss (Geschätzt)

13. Juni 2028

Studienabschluss (Geschätzt)

13. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

21. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Juni 2026

Zuerst gepostet (Tatsächlich)

24. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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