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])

Sponsor
Chiesi Farmaceutici S.p.A.
Study ID
NCT07666490
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Jun 24, 2026
Start date
Jun 12, 2026
Status verified
Jun 2026
Primary completion
Jun 13, 2028
Completion
Jun 13, 2028

Study Design

Enrollment
644 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: BDP/FF/GB
    Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5 µg) - 2 inhalations bid
  • Active Comparator: BDP/FF
    Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid

Primary Outcome Measure

Change in ACQ-5 score [ Time Frame: Baseline to Month 12 (Visit 7) ]

Central Contacts

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