Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

• Status: Recruiting
• Trial end date: 2023-07-25
• Target enrollment: 0
• Participant gender: All

Summary

This is 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: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide, Formoterol Fumarate Drug Combination

Criteria

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) for at least 3 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.

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 > and/or = 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 Inhaled Corticosteroid/Long-Acting β2-Agonist (ICS/LABA) regimen (including a stable ICS dose), with medium to high ICS doses for at least 4 weeks prior to V1.

8. Electronic Diary (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 within 4 weeks of randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment within 4 weeks of randomization.

10. Demonstrate acceptable MDI/pMDI administration technique.

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 half-lives 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 Chronic Obstructive Pulmonary Disease (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 Long-Acting Muscarinic Antagonist (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 pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

Please refer to the study protocol for the complete inclusion and exclusion criteria list.