Stop Exogenous Allergic Alveolitis (EAA) in Childhood

NCT02631603 | Terminated Phase 2 Results DMC

• 1 other identifier: StopEAA
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 7

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.

Conditions

Hypersensitivity Pneumonitis; Exogenous Allergic Alveolitis

Keywords

Children; Birds; Moulds

Outcome Measures

Primary Outcomes (1)

• Forced Vital Capacity (FVC).

  The relative change from baseline through month 6 compared to change from placebo of FVC.

  6 months

Secondary Outcomes (1)

• Forced Vital Capacity (FVC)

  3 months

Study Arms (2)

Placebo

EXPERIMENTAL

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

Drug: Placebo

Prednisolone

ACTIVE COMPARATOR

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.

Drug: Prednisolone

Interventions

Placebo DRUG

Administer Placebo as anti-inflammatory

Also known as: no other name

Placebo

Prednisolone DRUG

Administer Prednisolone as anti-inflammatory

Also known as: Decortin H

Prednisolone

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Unchanged inhaled steroids if on; if off, no plans to introduce them in the following 6 months
• Agreement to home visit by independent study physician

You may not qualify if:

• Contraindication for usage systemic steroids
• Critically ill patients needing respiratory support
• Non-compliance with medical treatments and interventions
• 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.
• Pregnancy and lactation.
• 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.

Sponsors & Collaborators

• Matthias Griese: lead

Study Sites (7)

Klinikum der Universität München, Haunersches Kinderspital

München, Bavaria, 80337, Germany

Location

Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose

Frankfurt am Main, Hesse, 60590, Germany

Location

Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie

Giessen, Hesse, 35385, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

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

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Uniklinikum Essen, Pädiatrische Pneumologie

Essen, North Rhine-Westphalia, 45122, Germany

Location

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

Leipzig, Saxony, 04103, Germany

Location

Related Publications (1)

• 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.

  PMID: 34048641 RESULT

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Interventions

Prednisolone; Methylprednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The major limitation of this trial was its premature closure and the small number of patients included. This was due to several reasons: the study design was developed as work package within a limited research project. The anticipated enrolment was lower than expected. There was a lack of resources to carry on the clinical trial for the many years in view of the much lower incidences of this rare conditions than calculated before on available data.

Results Point of Contact

• Title: Prof. Dr. med. Matthias Griese
• Organization: LMU/ Haunersches Kinderspital

matthias.griese@med.uni-muenchen.de

+498944000

Study Officials

• Matthias Griese, Prof., MD

  Pediatric Pneumology, Ludwig-Maximilians-University Munich

  STUDY DIRECTOR

• Meike Hengst, MD

  Pediatric Pneumology, Ludwig-Maximilians University Munich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: November 29, 2015
• First Posted: December 16, 2015
• Study Start: April 1, 2015
• Primary Completion: July 11, 2016
• Study Completion: June 16, 2020
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)