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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4
Administer Placebo as anti-inflammatory
Administer Prednisolone as anti-inflammatory
Klinikum der Universität München, Haunersches Kinderspital
München, Bavaria, Germany
Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose
Frankfurt am Main, Hesse, Germany
Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie
Giessen, Hesse, Germany
Forced Vital Capacity (FVC).
The relative change from baseline through month 6 compared to change from placebo of FVC.
Time frame: 6 months
Forced Vital Capacity (FVC)
FVC measured in accordance to standarized protocol.
Time frame: 3 months
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Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
Bochum, North Rhine-Westphalia, Germany
Uniklinikum Essen, Pädiatrische Pneumologie
Essen, North Rhine-Westphalia, Germany
Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig
Leipzig, Saxony, Germany