Asthma control with a single inhaler triple therapy vs a standard inhaler in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4, pragmatic, randomized, open-label study compares two inhaled regimens in adults with poorly controlled asthma. Participants must have used medium-dose ICS/LABA for at least 3 months and have ACQ-5 scores indicating poor control, with at least one exacerbation in the prior year. The trial uses a parallel-group design across multiple centers to assess asthma control outcomes between Beclometasone/formoterol/glycopyrronium (100/6/12.5 μg per actuation) BID and Beclometasone/formoterol (200/6 μg BID). It leverages patient-reported outcomes via a study app and requires participant training for accurate ePRO measurements. The study is sponsored by Chiesi Farmaceutici S.p.A. and conducted at the Medical Center Hermes Ruse in Rousse.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical Center Hermes Ruse LTD 12 Chavdar Voyvoda St.
  Rousse, Bulgaria Recruiting

Study contacts

• Study coordinator: Clinical Trial INFO Chiesi Farmaceutici S.p.A.
• Email: clinicaltrials_info@chiesi.com
• Phone: +39 0521 2791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.