Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT02631603
Status:
TERMINATED
Last Update Posted:
2024-12-18
First Post:
2015-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stop Exogenous Allergic Alveolitis (EAA) in Childhood
Sponsor:
Matthias Griese
Organization:
Study Overview
Official Title:
Stop Exogenous Allergic Alveolitis (EAA) in Childhood: Healthy Into Adulthood - A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prednisolone Treatment and Course of Disease
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After several years of recruitment only 4 patients were included. Study timelines for study completition too long. Decided to terminate trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
chILD-EU_EAA
Brief Summary:
Stop exogenous allergic alveolitis (EAA) or hypersensitivity pneumonitis in childhood: healthy into adulthood - a randomized, double-blind, placebo-controlled, parallel-group study to evaluate prednisolone treatment and course of disease.
The hypothesis of the study is that the treatment with placebo will not be inferior in terms of Forced Vital Capacity (FVC) improvement than treatment with systemic steroids after 6 months treatment.
The hypothesis of the study is that the treatment with placebo will not be inferior in terms of Forced Vital Capacity (FVC) improvement than treatment with systemic steroids after 6 months treatment.
Detailed Description:
After an initial steroid pulse given to all patients, patients will be allocated to the two treatments, i.e., oral prednisolone and Placebo.
Experimental intervention: Placebo Control intervention: Prednisolone Duration of intervention per patient: 3 months Follow-up per patient: 3 months
Primary Objective:
To evaluate outcome of EAA at 6 months and compare the medium term treatment with systemic steroids or placebo.
Secondary Objectives:
To evaluate the completeness and knowledge of standardized and pedantic allergen elimination in families with a child with EAA.
To evaluate the treatment of EAA with systemic steroids compared to placebo at 3 months.
To evaluate the safety of the treatment of EAA with outpatient usage of systemic steroids compared to Placebo.
Experimental intervention: Placebo Control intervention: Prednisolone Duration of intervention per patient: 3 months Follow-up per patient: 3 months
Primary Objective:
To evaluate outcome of EAA at 6 months and compare the medium term treatment with systemic steroids or placebo.
Secondary Objectives:
To evaluate the completeness and knowledge of standardized and pedantic allergen elimination in families with a child with EAA.
To evaluate the treatment of EAA with systemic steroids compared to placebo at 3 months.
To evaluate the safety of the treatment of EAA with outpatient usage of systemic steroids compared to Placebo.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: