exogenous allergic alveolitis (EAA) MedDRA version: 17.1 Level: PT Classification code 10001890 Term: Alveolitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Decortin® H Tabletten
Product Name: Prednisolon
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisolone
CAS Number: 125-02-0
Other descriptive name: PREDNISOLONE SODIUM PHOSPH
Sponsors
Klinikum der Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate outcome of EAA at 6 months and compare medium term treatment with systemic steroids or placebo. ;Secondary Objective: 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;Primary end point(s): Relative change from baseline through month 6 compared to change from placebo for * forced vital capacity (FVC);Timepoint(s) of evaluation of this end point: month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Each patient will be classified as a responder or non-responder. A patient is considered as a responder, if the FVC value after 6 months is more than or equal to 93% of the norm values tabulated by Quanjer PH., et al. 2013. Relative change from baseline through month 6 compared to change from placebo for * desaturation with standardized exercise test for children * Borg scale * Quality-of-life * Health economics * Weight for height * Open usage of rescue glucocorticosteroids (mg/kg/6 months) Relative change from baseline through month 3 compared to change from placebo for * forced vital capacity FVC * desaturation with standardized exercise test for children * Borg scale * Quality-of-life * Health economics * Weight for height * Open usage of rescue glucocorticosteroids (mg/kg/6 months) Assessment of safety: * Adverse events * Clinical laboratory values (GOT, Creatinine, gGT, blood count, differential, LDH, HbA1c) * Safety values including blood pressure, height.;Timepoint(s) of evaluation of this end point: month 6, month 3 | — |
Countries
Germany
Contacts
Public ContactMatthias Griese
Klinikum der Universität München
Outcome results
None listed