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

Study identifier:D5982C00007

ClinicalTrials.gov identifier:NCT04609878

EudraCT identifier:2020-001520-34

CTIS identifier:2023-505787-11-00

Recruitment Complete

Official Title

A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants with Inadequately Controlled Asthma

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

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

Sex

All

Actual Enrollment

2212

Study type

Interventional

Age

12 Years - 80 Years

Date

Study Start Date: 15 Dec 2020
Estimated Primary Completion Date: 21 Mar 2025
Estimated Study Completion Date: 21 Mar 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria