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 (KALOS)

AstraZeneca AB,0 sites0 target enrollmentJune 14, 2021

Conditions-J459 Asthma, unspecified Asthma, unspecified J459

Overview

Phase: 未知
Intervention: Not specified
Conditions: -J459 Asthma, unspecified
Sponsor: AstraZeneca AB,
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 14, 2021

End Date

March 3, 2022

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

AstraZeneca AB,

Eligibility Criteria

Inclusion Criteria

•5\.1Inclusion Criteria
•1\-Participant must be at least 12 to 80 years of age inclusive, at the time of signing the ICF.
•Note: For participants from 12 to \<18 years of age, their parents or legal guardians must give their signed written informed consent, as appropriate, and participants will sign an assent form.
•2\-Participants who have a documented history of physician\-diagnosed asthma ≥1 year prior to Visit 1, according to GINA guidelines \[GINA 2020]. Healthcare records for 1 year prior to Visit 1 must be provided for adolescent participants (12 to \<18 years of age) to ensure consistent evaluation and follow\-up of treatment in those participants.
•3\-Participants who have been regularly using a stable daily ICS/LABA regimen (including a stable ICS dose), with the ICS doses allowed in Table 7, for at least 4 weeks prior to Visit 1\.Have a documented history of at least one asthma exacerbation requiring use of systemic corticosteroids (oral or IV) for at least 3 days AND an associated physician visit, hospitalization, or ER visit due to asthma (within 3 days of the corticosteroid use) in the 12 months prior to Visit 1\.
•Note: This criterion does not apply for participants 12 to \<18 years of age.
•5\-ACQ\-7 total score ≥1\.5 at Visits 1, 3, and 5 (pre\-randomization).
•6\-A pre\-bronchodilator FEV1 \<80% predicted normal value at Visits 1, 2, 3, 4, and 5 (pre\-randomization) for participants ≥18 years of age OR a pre\-bronchodilator FEV1 \<90% predicted normal value at Visits 1, 2, 3, 4, and 5 (pre\-randomization) for participants 12 to \<18 years of age.
•Note: Participants who have not withheld asthma medications prior to Visit 1 and failed spirometry testing at Visit 1 should return to the clinic to repeat spirometry testing within two days. If repeat spirometry failed, then participants must be screen\-failed.
•7Documented reversibility to albuterol, which is defined as a post\-albuterol increase in FEV1 of ≥12% and ≥200 mL for participants ≥18 years of age OR a post\-albuterol increase of FEV1 of ≥12% for participants 12 to \<18 years of age at Visit 2, or at Visit 3 if repeat testing necessary.

Exclusion Criteria

•5\.2Exclusion Criteria
•1Life\-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).
•2Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of Visit 1\.
•3Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.
•4Hospitalization for asthma within 2 months of Visit 1\.
•5Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (e.g., active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
•6Known history of drug or alcohol abuse within 12 months of Visit 1\.
•7Narrow 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\.
•Note: All medications approved for control of intraocular pressures are allowed, including topical ophthalmic non\-selective beta\-blockers.
•8Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the Investigator, is clinically significant.