Allergic Alveolitis Clinical Trial
— chILD-EU_EAAOfficial 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
| NCT number | NCT02631603 |
| Other study ID # | StopEAA |
| Secondary ID | |
| Status | Suspended |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | April 2015 |
| Est. completion date | April 2024 |
| Verified date | March 2019 |
| Source | Ludwig-Maximilians - University of Munich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
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.
| Status | Suspended |
| Enrollment | 45 |
| Est. completion date | April 2024 |
| Est. primary completion date | April 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 25 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital | Bochum | Nordrhein-Westfalen |
| Germany | Uniklinikum Essen, Pädiatrische Pneumologie | Essen | Nordrhein-Westfalen |
| Germany | Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose | Frankfurt | Hessen |
| Germany | Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie | Gießen | Hessen |
| Germany | Medizinische Hochschule Hannover | Hannover | Niedersachsen |
| Germany | Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig | Leipzig | Sachsen |
| Germany | Klinikum der Universität München, Haunersches Kinderspital | München | Bayern |
| Lead Sponsor | Collaborator |
|---|---|
| Matthias Griese |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The relative change from baseline through month 6 compared to change from placebo for forced vital capacity (FVC). | 6 months | ||
| Secondary | 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 | 6 months | ||
| Secondary | Forced vital capacity (FVC) | 3 months | ||
| Secondary | Desaturation with standardized exercise test for children | 3 and 6 months | ||
| Secondary | Borg scale | 3 and 6 months | ||
| Secondary | Quality-of-life | 3 and 6 months | ||
| Secondary | Costs of care in € | 3 and 6 months | ||
| Secondary | Weight for height (%) | Calculated from current weight * 100 / weight median for height of subject | 3 and 6 months | |
| Secondary | Open usage of rescue glucocorticosteroids (mg/kg/6 months) | 3 and 6 months |