Clinical Trial: Stop Exogenous Allergic Alveolitis (EAA) in Childhood

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Stop Exogenous Allergic Alveolitis (EAA) in Childhood: Healthy Into Adulthood - A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prednisolo

Brief Summary:

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.

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 Summary:

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.


Sponsor: Matthias Griese

Current Primary Outcome: The relative change from baseline through month 6 compared to change from placebo for forced vital capacity (FVC). [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Each patient will be classified as a responder or non-responder. A patient is considered as a responder, if the FVC value after 6 months is more than or equal to 93% of the norm values tabulated by Quanjer PH., et al. 2013 [ Time Frame: 6 months ]
  • Forced vital capacity (FVC) [ Time Frame: 3 months ]
  • Desaturation with standardized exercise test for children [ Time Frame: 3 and 6 months ]
  • Borg scale [ Time Frame: 3 and 6 months ]
  • Quality-of-life [ Time Frame: 3 and 6 months ]
  • Costs of care in € [ Time Frame: 3 and 6 months ]
  • Weight for height (%) [ Time Frame: 3 and 6 months ]
    Calculated from current weight * 100 / weight median for height of subject
  • Open usage of rescue glucocorticosteroids (mg/kg/6 months) [ Time Frame: 3 and 6 months ]


Original Secondary Outcome: Same as current

Information By: Ludwig-Maximilians - University of Munich

Dates:
Date Received: November 29, 2015
Date Started: April 2015
Date Completion: April 2018
Last Updated: September 7, 2016
Last Verified: September 2016