A Variable Length Study to Evaluate the Efficacy and Safety of Budesonide/Glycopyrronium/Formoterol inhaler in Adults and Adolescents with Severe Asthma Inadequately Controlled with Standard of Care.

Phase 1

• Conditions: Severe and inadequately controlled asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001520-34-IT
• Lead Sponsor: ASTRAZENECA AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

1. Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.

2. Documented history of at least one asthma exacerbation requiring use of systemic corticosteroids (SCS) (oral or IV) and any combination thereof for at least 3 consecutive days and an associated physician visit, hospitalization, or emergency room visit due to asthma (within 3 days of the corticosteroid use) in the 12 months prior to V1 (Not applicable to adolescents).

3. 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.

4. FEV1 post-albuterol at V2 or V3 (if repeat needed).

• Participants > and/or = 18 years of age: Increase > and/or = 12%

and > and/or = 200 mL.

• Participants 12 to <18 years of age: Increase =12%.

5. FEV1 % predicted normal at V1, 2, 3, 4, and 5 (pre-randomization).

• Participants > and/or = 18 years of age: < 80%

• Participants 12 to <18 years of age: < 90%

6. ACQ-7 total score > and/or = 1.5 at V1, 3, 5.

7. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose), with medium to high ICS doses for at least 4 weeks prior to V1.

8. eDiary compliance > and/or = 70% during screening (defined as completed daily eDiary entry and answering yes for taking 2 puffs of run-in BFF MDI for any 10 mornings, and any 10 evenings in the last 14

days prior to randomization).

9. No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.

10. Demonstrate acceptable MDI/pMDI administration technique.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2394
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 326

Exclusion Criteria

1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.

2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.

2b. Any marketed or investigational biologics within 3 months or 5 halflives of V1, whichever is longer and must not be used during study duration.

3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

4. Current evidence of COPD.

5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.

5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.

5c. Depot corticosteroid use for any reason within 12 months of V1.

6. Use of LAMA as maintenance treatment, either alone or as part of an inhaled combination therapy, within 12 months prior to V1.

7. Use of oral b2-agonist within 3 months of V1.

8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.

9. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.

10. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).

11. Hospitalization for asthma within 2 months of Visit 1.

12. Known history of drug or alcohol abuse within 12 months of Visit 1.

13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications.

14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.

15. Participation in another clinical study with an Investigational Product.

16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.

17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.

18. For women only – currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified