Stop Exogenous Allergic Alveolitis (EAA) in Childhood

Phase 2

Terminated

• Conditions: Hypersensitivity Pneumonitis; Exogenous Allergic Alveolitis
• Interventions: Drug: Placebo; Drug: Prednisolone

• Registration Number: NCT02631603
• Lead Sponsor: Matthias Griese

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-11-29
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Primary Completion: 2016-07-11
• Study Completion: 2020-06-16
• Results First Submitted: 2022-09-21
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Results First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Newly or previously diagnosed but not appropriately treated EAA in children, adolescents and young adults, aged between 3 and 25 years. The diagnosis of EAA must be confirmed by independent review of the findings by an expert panel and must be based on the presence of at least 4 of the following findings:

   • History of appropriate allergen exposure
   • Restrictive lung function (FVC < 80% predicted for age and FVC/FEV1 < 1) testing, if appropriate for age (usually > 5 y)
   • Positive serum precipitins for bird/fungus exposed to (other allergens have rarely, if every been demonstrated in children)
   • Lymphocytosis in BAL (> 20% of cells are lymphocytes)
   • HRCT showing the characteristic nodular, linear or reticular opacities, and ground glass pattern with increased attenuation.
   • Lung biopsy demonstrating lymphocytic alveolitis, bronchiolitis, and non-caseating histiocytic granulomatas.
   • Controlled allergen exposure followed by characteristic reaction, including fever, coughing, restriction on lung function, hypoxemia/desaturation at rest or with exercise

2. Unchanged inhaled steroids if on; if off, no plans to introduce them in the following 6 months

3. Agreement to home visit by independent study physician

Exclusion Criteria

1. Contraindication for usage systemic steroids
2. Critically ill patients needing respiratory support
3. Non-compliance with medical treatments and interventions
4. Women with childbearing potential and not practicing a medically accepted contraception during the trial and a positive pregnancy test (serum or urine) before and at the end of the trial. Reliable contraception are systematic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicide.
5. Pregnancy and lactation.
6. Participation in another trial for EAA during the last 4 weeks or not beyond the time of 4 half-lives of the medication used. In the unlikely event a subject is already in another clinical study but not for EAA, that study must be stopped and the subject may be treated according to this protocol; a latency time between the two studies does not appear reasonable, as acute intervention is necessary for EAA. Treatment may be best done in the frame work of this protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Capsules of placebo will be taken for 3 months, same schedule as verum.
Prednisolone	Prednisolone	Oral prednisolone, anticipated dose: first month 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.

Primary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC).	6 months	The relative change from baseline through month 6 compared to change from placebo of FVC.

Secondary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	3 months	FVC measured in accordance to standarized protocol.

Trial Locations

Locations (7)

Klinikum der Universität München, Haunersches Kinderspital; 🇩🇪 München, Bayern, Germany

Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose; 🇩🇪 Frankfurt, Hessen, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany

Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie; 🇩🇪 Gießen, Hessen, Germany

Uniklinikum Essen, Pädiatrische Pneumologie; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig; 🇩🇪 Leipzig, Sachsen, Germany