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Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA

NCT05018598 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2024-11-15

No results posted yet for this study

Summary

The purpose of this phase IV Study is to compare the efficacy of CHF5993 (BDP/FF/GB 100/6/12.5 pMDI) on uncontrolled asthma subjects, versus CHF1535 (BDP/FF 200/6 pMDI).

The open label extension part aims to assess the proportion of subjects whose asthma remains or becomes adequately controlled..

Conditions

Interventions

DRUG

Administration via pressurized metered dose inhaler (pMDI)

CHF5993 pMDI

DRUG

Administration via pressurized metered dose inhaler (pMDI)

CHF1535 pMDI or CHF5993 pMDI

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Kostantinos Kostikas · Head Respiratory Medicine Department, University Hospital of Ioannina, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-25
Primary Completion
2024-04-16
Completion
2024-04-16

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05018598 on ClinicalTrials.gov