Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT02631603
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.
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.
Study:
NCT02631603
Study Brief:
Protocol Section:
NCT02631603