Stop Exogenous Allergic Alveolitis (EAA) in Childhood (chILD-EU_EAA)

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

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.

Study Overview

• Status: Suspended
• Conditions: Allergic Alveolitis
• Intervention / Treatment: Drug: Placebo; Drug: Prednisolone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • München, Bayern, Germany, 80337
      • Klinikum der Universität München, Haunersches Kinderspital
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose
    • Gießen, Hessen, Germany, 35385
      • Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44791
      • Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
    • Essen, Nordrhein-Westfalen, Germany, 45122
      • Uniklinikum Essen, Pädiatrische Pneumologie
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Capsules of placebo will be taken for 3 months.	Drug: Placebo; Administer Placebo as anti-inflammatory; Other Names: no other name
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.	Drug: Prednisolone; Administer Prednisolone as anti-inflammatory; Other Names: Decortin H

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Matthias Griese
• Investigators: Study Director: Matthias Griese, Prof., MD, Pediatric Pneumology, Ludwig-Maximilians-University Munich; Principal Investigator: Meike Hengst, MD, Pediatric Pneumology, Ludwig-Maximilians University Munich

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: November 29, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases, Interstitial; Alveolitis, Extrinsic Allergic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: StopEAA