The impact of extra-fine inhalation corticosteroid particles on small-airway disease in Chronic Obstructive Pulmonary Disease (COPD): a randomized, prospective cross-over trial.

2025-524256-64-00 Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 60
Countries 1
Sites 1

Chronic Obstructive Pulmonary Disease

Key facts

Sponsor
CHU Saint Pierre
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Decision date (initial)
2026-01-19
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHU Saint Pierre

3 Total trials
Academic / Non-commercial
Sponsor organisation
CHU Saint Pierre
Address
Waterloolaan 129
City
Brussels
Postcode
1000
Country
Belgium

Scientific contact point

Organisation
CHU Saint Pierre
Contact name
Study Coordinator

Public contact point

Organisation
CHU Saint Pierre
Contact name
Study Coordinator

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Authorised, recruitment pending 60 1
Rest of world 0

Investigational sites

Belgium

1 site · Authorised, recruitment pending
CHU Saint Pierre
Pulmonology, Waterloolaan 129, 1000, Brussels

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-10-15 Belgium Acceptable with conditions
2026-01-19
2026-01-19