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])
| NCT ID | NCT07666490 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 644 participants |
| Start Date | 2026-06-28 |
| Primary Completion | 2028-06-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 644 participants in total. It began in 2026-06-28 with a primary completion date of 2028-06-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07666490 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07666490 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07666490 currently recruiting?
Yes, NCT07666490 is actively recruiting participants. Contact the research team at clinicaltrials_info@chiesi.com for enrollment information.
Where is the NCT07666490 trial being conducted?
This trial is being conducted at Rousse, Bulgaria.
Who is sponsoring the NCT07666490 clinical trial?
NCT07666490 is sponsored by Chiesi Farmaceutici S.p.A.. The trial plans to enroll 644 participants.
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