Clinical trial NCT02631603: Stop Exogenous Allergic Alveolitis (EAA) in Childhood
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypersensitivity Pneumonitis
Exogenous Allergic Alveolitis
Keywords: Children
Birds
Moulds
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Forced Vital Capacity (FVC).
timeFrame: 6 months
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: 3 months
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum der Universität München, Haunersches Kinderspital
state: Bayern
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose
state: Hessen
city: Gießen
country: Germany
facility: Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Bochum
country: Germany
facility: Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Uniklinikum Essen, Pädiatrische Pneumologie
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig
state: Sachsen
Study officials:
affiliation: Pediatric Pneumology, Ludwig-Maximilians-University Munich
name: Matthias Griese, Prof., MD
role: STUDY_DIRECTOR
affiliation: Pediatric Pneumology, Ludwig-Maximilians University Munich
name: Meike Hengst, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griese M, Stehling F, Schwerk N, Rosewich M, Jerkic PS, Rock H, Ruckes C, Kronfeld K, Sebah D, Wetzke M, Seidl E. Hypersensitivity pneumonitis: Lessons from a randomized controlled trial in children. Pediatr Pulmonol. 2021 Aug;56(8):2627-2633. doi: 10.1002/ppul.25513. Epub 2021 May 28.