A Phase 4 interventional study of Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation) and Foster® 200/6 pMDI (BDP/FF-200/6 µg) in Asthma, sponsored by Chiesi Farmaceutici S.p.A.. Recruiting at 1 site in Bulgaria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Chiesi Farmaceutici S.p.A. · Phase 4, Interventional, and Treatment
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.
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.
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:
Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5 µg) - 2 inhalations bid
Drug: Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation)
Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid
Drug: Foster® 200/6 pMDI (BDP/FF-200/6 µg)
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.
Also known as: Trimbow®
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.
Also known as: Foster®
Change in ACQ-5 score
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).
Time frame: Baseline to Month 12 (Visit 7)
Change from baseline in ACQ-5 at all applicable visits.
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).
Time frame: Baseline to Month 12 (Visit 7)
Rate of severe asthma exacerbations
Rate of severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months.
Time frame: Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
Rate of moderate/severe asthma exacerbations
Rate of moderate/severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months
Time frame: Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
Time to first severe asthma exacerbation.
Time to first severe asthma exacerbation.
Time frame: Month 12 treatment period
Time to first moderate/severe asthma exacerbation.
Time to first moderate/severe asthma exacerbation.
Time frame: Month 12 treatment period
Speed of change questionnaire at each applicable study visit.
Speed of change questionnaire at each applicable study visit.
Time frame: Month 12 treatment period
Eosinophils value
Change from baseline in eosinophils value at each applicable study visit.
Time frame: 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
Number of days with oral systemic corticosteroids
Time frame: Month 12 treatment period
Change from baseline in Test of Adherence to Inhalers (TAI) questionnaire at each applicable visit.
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.
Time frame: 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
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).
Time frame: 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)
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.
Time frame: 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
Percentage of study participants with cardiovascular and/or fatal events (considering standard adverse event \[AE\] data collection)
Time frame: 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
Percentage of study participants with partial and complete asthma remission at 6 and 12 months.
Time frame: Month 6 (Visit 4), Month 12 (Visit 7)
Change in Spirometry parameters: FEV1
Pulmonary function tests measured by spirometry: FEV1 (forced expiratory volume in 1 second), expressed as volume (L).
Time frame: 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
Pulmonary function tests measured by spirometry: FVC (forced vital capacity), expressed as volume (L).
Time frame: 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
Pulmonary function tests measured by spirometry: FEV1/FVC ratio, expressed as a percentage (%).
Time frame: 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
Pulmonary function tests measured by spirometry: FEF25-75 (forced expiratory flow between 25% and 75% of FVC), expressed as flow (L/s).
Time frame: 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
Pulmonary function tests measured by spirometry: ratio of FEF25-75 to FVC.
Time frame: 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%
Pulmonary function tests measured by spirometry: FEV1 as percentage of predicted normal values (%).
Time frame: 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
Pulmonary function tests measured by spirometry: FVC as percentage of predicted normal values (%).
Time frame: 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)
Pulmonary function tests measured by oscillometry: Resistance at 5 Hz (R5), representing total airway resistance, expressed in kPa·L-¹·s.
Time frame: 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)
Pulmonary function tests measured by oscillometry: Resistance at 20 Hz (R20), representing central airway resistance, expressed in kPa·L-¹·s.
Time frame: 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)
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.
Time frame: 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)
Pulmonary function tests measured by oscillometry: Reactance at 5 Hz (X5), reflecting distal airway reactance, expressed in kPa·L-¹·s.
Time frame: 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)
Pulmonary function tests measured by oscillometry: Resonant frequency (Fres), defined as the frequency at which reactance equals zero, expressed in Hz
Time frame: 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)
Pulmonary function tests measured by oscillometry: Area of reactance (AX), representing the integrated low-frequency reactance, expressed in Hz·kPa·L-¹·s.
Time frame: 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
Dose of oral systemic corticosteroids (mg)
Time frame: Month 12 treatment period
Plan to share: Yes — Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
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Chiesi Farmaceutici S.p.A.