Stop Exogenous Allergic Alveolitis (EAA) in Childhood

NCT ID: NCT02631603

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2020-06-16

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.

Conditions

Hypersensitivity Pneumonitis; Exogenous Allergic Alveolitis

Keywords

Children; Birds; Moulds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Capsules of placebo will be taken for 3 months, same schedule as verum.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Administer Placebo as anti-inflammatory

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.

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

Administer Prednisolone as anti-inflammatory

Interventions

Placebo

Administer Placebo as anti-inflammatory

Intervention Type: DRUG

Prednisolone

Administer Prednisolone as anti-inflammatory

Intervention Type: DRUG

Other Intervention Names

no other name; Decortin H

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matthias Griese

OTHER

Sponsor Role: lead

Responsible Party

Matthias Griese

Prof. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Matthias Griese, Prof., MD

Role: STUDY_DIRECTOR

Pediatric Pneumology, Ludwig-Maximilians-University Munich

Meike Hengst, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Pneumology, Ludwig-Maximilians University Munich

Locations

Klinikum der Universität München, Haunersches Kinderspital

München, Bavaria, Germany

Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose

Frankfurt am Main, Hesse, Germany

Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie

Giessen, Hesse, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital

Bochum, North Rhine-Westphalia, Germany

Uniklinikum Essen, Pädiatrische Pneumologie

Essen, North Rhine-Westphalia, Germany

Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig

Leipzig, Saxony, Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 34048641 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

StopEAA

Identifier Type: -

Identifier Source: org_study_id