Glycopyrronium bromide; Formoterol fumarate dihydrate; Beclometasone dipropionate (anhydrous) for Asthma|Mild to moderate asthma

Inclusion criteria

• {"criterion_text":"- 1. Informed consent: obtained prior to any study-related procedure"}
• {"criterion_text":"- 10. Rescue medication: subjects must be able to replace their current rescue medication with a salbutamol (i.e. albuterol) inhaler for use as needed for the duration of the study"}
• {"criterion_text":"- 11. Current therapy: subjects must be able to safely discontinue their asthma medications (ICS with or without LABA) during the run-in period and for the remainder of the study"}
• {"criterion_text":"- 12. Spacer non-use: subjects must be able to inhale the study treatment without using a spacer"}
• {"criterion_text":"- 13. Subjects must have a willingness and ability to: a. Be trained to correctly use the pMDI inhalers and the electronic diary (e-Diary); b. Read/write; c. Perform all study-related procedures, including technically acceptable spirometry and e-Diary completion; d. Understand the risks involved"}
• {"criterion_text":"- 14. Female subjects: a. Woman of childbearing potential (WOCBP) using a highly effective birth control method (refer to protocol for more details) or b. Women of non-childbearing potential"}
• {"criterion_text":"- 2. Sex and age: male and female adults aged ≥18 and ≤75 years"}
• {"criterion_text":"- 3. Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive"}
• {"criterion_text":"- 4. Smoking status: non-smokers or ex-smokers who smoked ≤10 pack-years prior to screening"}
• {"criterion_text":"- 5. Diagnosis of asthma: documented physician-diagnosed asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years"}
• {"criterion_text":"- 6. Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with: a.low or medium doses of ICS alone; or b.low or medium doses of ICS + LABA (fixed or free combination). Low and medium doses of ICS are defined as non-extrafine BDP 200-500 μg and >500-1000 μg respectively, or estimated clinically comparable dose per the Global Initiative for Asthma 2024"}
• {"criterion_text":"- 7. Asthma control: controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score <1.5 at screening and at randomisation"}
• {"criterion_text":"- 8. Lung function: pre-BD FEV1 >40% and <90% of the predicted normal value, after appropriate wash-out from BDs, at the Screening Visit (V1)"}
• {"criterion_text":"- 9. Bronchodilator responsiveness: a demonstrated increase in either FEV1 or forced vital capacity of >12% and >200 mL from baseline within 30 minutes (min) after inhalation of 400 μg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1)"}

Exclusion criteria

• {"criterion_text":"- 1. History of high-risk asthma: history of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk"}
• {"criterion_text":"- 10. Electrocardiogram (ECG) criteria: any clinically significant abnormal 12-lead ECG that, in the Investigator’s opinion, would affect efficacy or safety evaluations or place the subjects at risk"}
• {"criterion_text":"- 11. ECG QTcF: male subjects with a QT interval corrected using Fridericia’s formula (QTcF) >450 milliseconds (ms) and female subjects with a QTcF >470 ms at Screening Visit (V1) are not eligible"}
• {"criterion_text":"- 12. Other medical conditions: previous medical history, evidence of an uncontrolled, severe, intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis"}
• {"criterion_text":"- 13. Concurrent diseases: subjects with a medical history or current diagnosis of narrow-angle glaucoma, symptomatic prostatic hypertrophy, urinary retention, or bladder neck obstruction that, in the opinion of the Investigator, would prevent the use of anticholinergic agents"}
• {"criterion_text":"- 14. Subjects receiving non-selective β2-blockers, quinidine and quinidine-like anti-arrhythmics, tricyclic anti-depressants, monoamine oxidase inhibitors, cytochrome P450 3A4 inhibitors and non-potassium sparing diuretics within 4 weeks prior to screening (unless the diuretic is administered as a fixed-dose combination with a potassium-conserving drug)"}
• {"criterion_text":"- 15. Contra-indications to IMPs. For warnings, eligibility will be judged by the Investigator"}
• {"criterion_text":"- 16. History of hypersensitivity to any components of the study treatments or a history of other allergies that, in the opinion of the Investigator, contraindicates the subject’s participation"}
• {"criterion_text":"- 17. Non-permitted concomitant medications: subjects receiving treatment with one or more drugs listed in the non-permitted concomitant medications section"}
• {"criterion_text":"- 18. Clinical evidence of candidiasis at the oropharyngeal examination at screening or randomisation (to be re-checked at randomisation)"}
• {"criterion_text":"- 19. Documented coronavirus disease 2019 (COVID-19) diagnosis within 2 weeks prior to screening, or associated complications/symptoms, which have not resolved within 14 days prior to screening (to be re-checked at randomisation)"}
• {"criterion_text":"- 2. Recent asthma exacerbation: asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period (to be checked again at randomisation)"}
• {"criterion_text":"- 20. Alcohol/drug abuse: subjects with a known or suspected history of alcohol and/or substance/drug abuse within 12 months prior to screening (to be re-checked at randomisation)"}
• {"criterion_text":"- 21. Participation in other investigational studies: subjects who have received any investigational drug within the 30 days (60 days for biologics) or approximately 5 half-lives of the investigational drug (whichever is longer) prior to screening, or who have been previously randomized in this study, or who are currently participating in another clinical study (to be re-checked at randomisation)"}
• {"criterion_text":"- 22. Pregnant or lactating women"}
• {"criterion_text":"- 23. Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation"}
• {"criterion_text":"- 24. Vaccination: subjects having received a vaccination within 2 weeks prior to screening or during the run-in period (to be rechecked at randomisation)"}
• {"criterion_text":"- 3. Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine"}
• {"criterion_text":"- 4. Asthma subjects currently treated with any of the following: a. High dose ICS; b. Long-acting muscarinic antagonist (LAMA); c. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening; d. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening; e. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening"}
• {"criterion_text":"- 5. Respiratory disorders other than asthma: any concomitant respiratory disorder other than asthma that, in the opinion of the Investigator and/or Medical Monitor, will interfere with the evaluation of the investigational medicinal product (IMP) or interpretation of subject safety or study results"}
• {"criterion_text":"- 6. Lung resection: subjects with a history of lobectomy, pneumonectomy or other sizable lung volume resection (total volume of lung removed >25%)"}
• {"criterion_text":"- 7. Lower respiratory tract infection: subjects with lower respiratory tract infection that required use of antibiotics, if unresolved within 4 weeks prior to screening or if occurring during the run-in period (to be re-checked at randomisation)"}
• {"criterion_text":"- 8. Lung cancer and history of lung cancer: subjects with and active diagnosis of lung cancer or a history of lung cancer"}
• {"criterion_text":"- 9. Subjects with active cancer or a history of cancer (other than lungs) with less than 5 years disease-free survival time (whether or not there is evidence of local recurrence or metastases). Localised carcinoma (e.g. basal cell carcinoma, in situ carcinoma of the cervix adequately treated) is acceptable"}

Primary endpoints

• {"endpoint_text":"- • Change from baseline in FEV1 AUC0-4h on Day 1\n- • Change from baseline in pre-dose FEV1 on Day 28","definition_or_measurement_approach":"Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (AUC0-4h) on Day 1 and change from baseline in pre-dose FEV1 on Day 28; measured by spirometry (FEV1) with AUC calculation for 0–4 h post-dose (Day 1) and pre-dose spirometry (Day 28)."}

Secondary endpoints

• {"endpoint_text":"- Relative and absolute change from pre-dose FEV1 at all post-dose timepoints at each visit","definition_or_measurement_approach":"Measured by spirometry (FEV1) at specified post-dose timepoints at each visit; reported as relative (%) and absolute (mL) change from pre-dose FEV1."}
• {"endpoint_text":"- Number and percentage of subjects with a >15% relative decrease from pre-dose in FEV1 at any post-dose timepoint at each visit","definition_or_measurement_approach":"Determined from spirometry (FEV1) measurements at post-dose timepoints; count and proportion of subjects meeting >15% relative decrease vs pre-dose at any post-dose timepoint."}
• {"endpoint_text":"- Change from pre-dose FEV1 area under the curve from time 0 to 2 h (AUC0-2h) on Day 28","definition_or_measurement_approach":"Change from pre-dose in FEV1 AUC0-2h on Day 28 measured by spirometry and AUC calculation for 0–2 h post-dose."}
• {"endpoint_text":"- Change from baseline (Day 1) in ACQ-7 scores on Day 28","definition_or_measurement_approach":"Change in Asthma Control Questionnaire - 7 Items (ACQ-7) score from baseline (Day 1) to Day 28 using patient-reported ACQ-7."}
• {"endpoint_text":"- Average daily use of rescue medication (number of puffs/day), percentage of days without intake of rescue medication and percentage of asthma control days during the TP","definition_or_measurement_approach":"Rescue medication use recorded (puffs/day) via e-Diary; calculation of average daily puffs, percent days without rescue medication, and percent asthma-control days during treatment period (TP)."}
• {"endpoint_text":"- Average morning and evening PEF and average daily symptoms during TP","definition_or_measurement_approach":"Peak expiratory flow (PEF) measured morning and evening (patient measurements) and symptom scores recorded daily via e-Diary; averages computed over the TP."}

Methods

• Flyers (patient-facing) distributed at sites and local clinics (country-specific flyers available: e.g., PL, HU, LV, CZ, DE, RO, SK, BG)
• Patient brochures and posters (country/language-specific patient brochure and poster materials provided for recruitment)
• Online outreach text (digital recruitment content / online adverts) with country-specific language versions
• Video scripts for recruitment videos (country-specific video scripts provided)
• K1 Recruitment and Informed Consent Procedure Forms (site-level recruitment procedures and consenting templates)
• Site-level recruitment via participating hospital/clinic sites (site contact details provided per country)

Bulgaria

Earliest CTIS Part Ii Submission Date

08-02-2026

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

32

Number Of Participants

42

Czechia

Earliest CTIS Part Ii Submission Date

17-12-2025

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

84

Number Of Participants

20

Germany

Earliest CTIS Part Ii Submission Date

19-12-2025

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

98

Number Of Participants

63

Hungary

Earliest CTIS Part Ii Submission Date

19-12-2025

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

83

Number Of Participants

18

Latvia

Earliest CTIS Part Ii Submission Date

22-01-2026

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

48

Number Of Participants

8

Poland

Earliest CTIS Part Ii Submission Date

03-02-2026

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

97

Number Of Participants

58

Romania

Earliest CTIS Part Ii Submission Date

06-03-2026

Latest Decision Or Authorization Date

19-03-2026

Processing Time Days

13

Number Of Participants

27

Slovakia

Earliest CTIS Part Ii Submission Date

14-11-2025

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

116

Number Of Participants

14

Primary sponsor

Full Name

Chiesi Farmaceutici S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Contract research organisations

Name

Advarra Inc.

Responsibilities

Site Investigator Portal: site communication, housing of study level documents

Name

Fortrea Inc.

Responsibilities

Medical monitoring, regulatory and sponsor support duties (multiple sponsor duty codes listed)

Name

Merge LLC

Responsibilities

Providing patient recruitment materials (translating, printing and shipping)

Name

Datacubed Health Inc.

Responsibilities

Data services

Third parties

• {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Site Investigator Portal: site communication, housing of study level documents","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Merge LLC","duties_or_roles":"Providing patient recruitment Materials (translating, printing and shipping of these documents)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"Laboratory services (duty code 4)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Secondary packaging and labeling of medicinal product","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Pharma Services Limited","duties_or_roles":"Duties code 3 (as listed)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG and Spirometry","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Multiple sponsor duties including medical monitoring, regulatory/submissions and other sponsor tasks (codes 1,12,15,2,5,8 listed)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Datacubed Health Inc.","duties_or_roles":"Data-related services (duty code 7)","organisation_type":"Pharmaceutical company"}