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

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ClinicalTrials.gov Identifier: NCT02631603
Recruitment Status : Suspended (funding pending)
First Posted : December 16, 2015
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Matthias Griese, Ludwig-Maximilians - University of Munich

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Allergic Alveolitis Drug: Placebo Drug: Prednisolone Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2015
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2024


Arm Intervention/treatment
Experimental: Placebo
Capsules of placebo will be taken for 3 months.
Drug: Placebo
Administer Placebo as anti-inflammatory
Other Name: 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 Name: Decortin H




Primary Outcome Measures :
  1. The relative change from baseline through month 6 compared to change from placebo for forced vital capacity (FVC). [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Forced vital capacity (FVC) [ Time Frame: 3 months ]
  3. Desaturation with standardized exercise test for children [ Time Frame: 3 and 6 months ]
  4. Borg scale [ Time Frame: 3 and 6 months ]
  5. Quality-of-life [ Time Frame: 3 and 6 months ]
  6. Costs of care in € [ Time Frame: 3 and 6 months ]
  7. Weight for height (%) [ Time Frame: 3 and 6 months ]
    Calculated from current weight * 100 / weight median for height of subject

  8. Open usage of rescue glucocorticosteroids (mg/kg/6 months) [ Time Frame: 3 and 6 months ]


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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631603


Locations
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Germany
Klinikum der Universität München, Haunersches Kinderspital
München, Bayern, Germany, 80337
Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose
Frankfurt, Hessen, Germany, 60590
Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie
Gießen, Hessen, Germany, 35385
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
Bochum, Nordrhein-Westfalen, Germany, 44791
Uniklinikum Essen, Pädiatrische Pneumologie
Essen, Nordrhein-Westfalen, Germany, 45122
Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig
Leipzig, Sachsen, Germany, 04103
Sponsors and Collaborators
Matthias Griese
Investigators
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Study Director: Matthias Griese, Prof., MD Pediatric Pneumology, Ludwig-Maximilians-University Munich
Principal Investigator: Meike Hengst, MD Pediatric Pneumology, Ludwig-Maximilians University Munich

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Responsible Party: Matthias Griese, Prof. Dr. med., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02631603     History of Changes
Other Study ID Numbers: StopEAA
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Alveolitis, Extrinsic Allergic
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents