NCT02631603

Stop Exogenous Allergic Alveolitis (EAA) in Childhood

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Matthias Griese · Academic / Other
• Sex: All
• Age: 6 Years – 25 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypersensitivity Pneumonitis
• Exogenous Allergic Alveolitis

Interventions

Type	Name	Description
DRUG	Placebo	Administer Placebo as anti-inflammatory
DRUG	Prednisolone	Administer Prednisolone as anti-inflammatory

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-07-11
• Completion: 2020-06-16
• First posted: 2015-12-16
• Last updated: 2024-12-18
• Results posted: 2024-12-18

Locations

7 sites across 1 country: Germany