Stop Exogenous Allergic Alveolitis (EAA) in Childhood (chILD-EU_EAA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02631603|
Recruitment Status : Suspended (funding pending)
First Posted : December 16, 2015
Last Update Posted : March 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Allergic Alveolitis||Drug: Placebo Drug: Prednisolone||Phase 2|
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
To evaluate outcome of EAA at 6 months and compare the medium term treatment with systemic steroids or Placebo.
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 (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2024|
Capsules of placebo will be taken for 3 months.
Administer Placebo as anti-inflammatory
Other Name: no other name
Active Comparator: Prednisolone
Oral prednisolone, anticipated dose:
first month after steroid pulse 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.
Individual capsules will be prepared using rounded dose.
Administer Prednisolone as anti-inflammatory
Other Name: Decortin H
- The relative change from baseline through month 6 compared to change from placebo for forced vital capacity (FVC). [ Time Frame: 6 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631603
|Klinikum der Universität München, Haunersches Kinderspital|
|München, Bayern, Germany, 80337|
|Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose|
|Frankfurt, Hessen, Germany, 60590|
|Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie|
|Gießen, Hessen, Germany, 35385|
|Medizinische Hochschule Hannover|
|Hannover, Niedersachsen, Germany, 30625|
|Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital|
|Bochum, Nordrhein-Westfalen, Germany, 44791|
|Uniklinikum Essen, Pädiatrische Pneumologie|
|Essen, Nordrhein-Westfalen, Germany, 45122|
|Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig|
|Leipzig, Sachsen, Germany, 04103|
|Study Director:||Matthias Griese, Prof., MD||Pediatric Pneumology, Ludwig-Maximilians-University Munich|
|Principal Investigator:||Meike Hengst, MD||Pediatric Pneumology, Ludwig-Maximilians University Munich|