Stop allergic alveolitis in childhood

Phase 1

• Conditions: exogenous allergic alveolitis (EAA); MedDRA version: 17.1Level: PTClassification code 10001890Term: Alveolitis allergicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-003689-15-DE
• Lead Sponsor: Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-17
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Newly or previously diagnosed but not appropriately treated EAA in children,
adolescents and young adults (3 to 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 45
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Contraindication for usage of systemic steroids
2. Critically ill patients needing respiratory support
3. Non-compliance with medical treatments and interventions
4. Not appropriate contraception in women of childbearing age, pregnancy and
lactation
5. 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 other trial. 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 clinical trial of medicinal product
• Study Design: Not specified