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

  • STATUS
    Recruiting
  • End date
    Jul 25, 2023
  • participants needed
    2800
  • sponsor
    AstraZeneca
Updated on 24 October 2021

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.

Description

This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2800 participants will be randomized globally.

Details
Condition Asthma, Allergies & Asthma, Asthma (Pediatric), asthmatic, bronchial asthma
Treatment BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg, BFF pMDI 320/9 μg
Clinical Study IdentifierNCT04609878
SponsorAstraZeneca
Last Modified on24 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1
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)
12 to 80 years of age, male and female, BMI <40 kg/m2
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%
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%
ACQ-7 total score > and/or = 1.5 at V1, 3, 5
Regularly using a stable daily Inhaled Corticosteroid/Long-Acting 2-Agonist (ICS/LABA) regimen (including a stable ICS dose), with medium to high ICS doses for at least 4 weeks prior to V1
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)
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
Demonstrate acceptable MDI/pMDI administration technique

Exclusion Criteria

Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1
a. Participants where, in the opinion of the Investigator, treatment with
biological therapy for asthma would be appropriate
b. 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
\. 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)
\. 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
c. 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
\. 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
\. 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
\. 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)
\. 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
\. Using any herbal products by inhalation or nebulizer within 4 weeks of
Visit 1 and does not agree to stop during the study duration
\. Participation in another clinical study with an Investigational Product
Participants with a known hypersensitivity to beta2-agonists
corticosteroids, anticholinergics, or any component of the MDI or pMDI
\. Study Investigators, sub-Investigators, coordinators, and their employees
or immediate family members
\. 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
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