Stop Exogenous Allergic Alveolitis (EAA) in Childhood

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2023

Detailed Description

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.

Interventions

  • Drug: Placebo
    • Administer Placebo as anti-inflammatory
  • Drug: Prednisolone
    • Administer Prednisolone as anti-inflammatory

Arms, Groups and Cohorts

  • Experimental: Placebo
    • Capsules of placebo will be taken for 3 months.
  • Active Comparator: Prednisolone
    • Oral prednisolone, anticipated dose: first month after steroid pulse 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.

Clinical Trial Outcome Measures

Primary Measures

  • The relative change from baseline through month 6 compared to change from placebo for forced vital capacity (FVC).
    • Time Frame: 6 months

Secondary Measures

  • 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
    • Time Frame: 6 months
  • Forced vital capacity (FVC)
    • Time Frame: 3 months
  • Desaturation with standardized exercise test for children
    • Time Frame: 3 and 6 months
  • Borg scale
    • Time Frame: 3 and 6 months
  • Quality-of-life
    • Time Frame: 3 and 6 months
  • Costs of care in €
    • Time Frame: 3 and 6 months
  • Weight for height (%)
    • Time Frame: 3 and 6 months
    • Calculated from current weight * 100 / weight median for height of subject
  • Open usage of rescue glucocorticosteroids (mg/kg/6 months)
    • Time Frame: 3 and 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Matthias Griese
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Matthias Griese, Prof. Dr. med. – Ludwig-Maximilians – University of Munich
  • Overall Official(s)
    • Matthias Griese, Prof., MD, Study Director, Pediatric Pneumology, Ludwig-Maximilians-University Munich
    • Meike Hengst, MD, Principal Investigator, Pediatric Pneumology, Ludwig-Maximilians University Munich

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