A 12-week study to assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS) - LITHOS

Study identifier:D5982C00005

ClinicalTrials.gov identifier:NCT05755906

EudraCT identifier:2021-003334-36

CTIS identifier:N/A

Recruitment Complete

Official Title

A Randomized, Double-Blind, Parallel Group, Multicenter 12 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

BFF MDI 160/9.6 μg BID (320/19.2μg/day), BD MDI 160 μg BID (320 μg/day)

Sex

All

Actual Enrollment

374

Study type

Interventional

Age

12 Years - 80 Years

Date

Study Start Date: 27 Feb 2023
Estimated Primary Completion Date: 15 Nov 2024
Estimated Study Completion Date: 15 Nov 2024

Study design

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

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria