Hypersensitivity PneumonitisPhase 2chILD-EU_EAANCT02631603
Stop Exogenous Allergic Alveolitis (EAA) in Childhood
A Phase 2 study testing Prednisolone in people with Hypersensitivity Pneumonitis and Exogenous Allergic Alveolitis, run by Matthias Griese at 7 sites in Germany.
Trial summary
Stop exogenous allergic alveolitis (EAA) or hypersensitivity pneumonitis in childhood: healthy into adulthood - a randomized, double-blind, placebo-controlled, parallel-group study to evaluate prednisolone treatment and course of disease. Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Hypersensitivity Pneumonitis, Exogenous Allergic Alveolitis
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 7 sitesGermany
- Study dates
- Apr 2015to 16 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
- Unchanged inhaled steroids if on; if off, no plans to introduce them in the following 6 months
- Agreement to home visit by independent study physician
Who cannot join
- Contraindication for usage systemic steroids
- Critically ill patients needing respiratory support
- Non-compliance with medical treatments and interventions
- 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.
- Pregnancy and lactation.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
Bochum, North Rhine-Westphalia, 44791
Uniklinikum Essen, Pädiatrische Pneumologie
Essen, North Rhine-Westphalia, 45122
Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose
Frankfurt am Main, Hesse, 60590
Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie
Giessen, Hesse, 35385
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig
Leipzig, Saxony, 04103
Klinikum der Universität München, Haunersches Kinderspital
München, Bavaria, 80337
About this study
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
Stop exogenous allergic alveolitis (EAA) or hypersensitivity pneumonitis 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.
Read the detailed description
After an initial steroid pulse given to all patients, 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.
- Being tested
- Placebo, Prednisolone
- Keywords
- Children, Birds, Moulds
- Medical subject headings
- Alveolitis, Extrinsic Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called no other name
Administer Placebo as anti-inflammatory
PrednisoloneDrug
Also called Decortin H
Administer Prednisolone as anti-inflammatory
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Capsules of placebo will be taken for 3 months, same schedule as verum. Receives: Drug: Placebo |
| Prednisolone | Active comparator | Oral prednisolone, anticipated dose:
first month 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. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC).
The relative change from baseline through month 6 compared to change from placebo of FVC.
Measured: 6 months
Secondary outcomes (1)
Forced Vital Capacity (FVC)
FVC measured in accordance to standarized protocol.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startApr 2015
- Primary completion11 Jul 2016
- Study completion16 Jun 2020
Why it stopped: After several years of recruitment only 4 patients were included. Study timelines for study completition too long. Decided to terminate trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthias Griese
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthias Griese, Ludwig-Maximilians - University of Munich
- Investigators
- Matthias Griese, Prof., MD, Study director, Pediatric Pneumology, Ludwig-Maximilians-University MunichMeike Hengst, MD, Principal investigator, Pediatric Pneumology, Ludwig-Maximilians University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631603
- Sponsor's protocol ID
- StopEAA
- Acronym
- chILD-EU_EAA
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2015
- Last updated
- 18 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Equivalent to product information sheet
Publications
Griese M, Stehling F, Schwerk N, Rosewich M, Jerkic PS, Rock H, Ruckes C, Kronfeld K, Sebah D, Wetzke M, Seidl E. Hypersensitivity pneumonitis: Lessons from a randomized controlled trial in children. Pediatr Pulmonol. 2021 Aug;56(8):2627-2633. doi: 10.1002/ppul.25513. Epub 2021 May 28.
PubMed 34048641
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02631603
- Acronym / sponsor ID
- chILD-EU_EAA / StopEAA
- Keywords
- Children, Birds, Moulds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After several years of recruitment only 4 patients were included. Study timelines for study completition too long. Decided to terminate trial.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Matthias GrieseUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 11 Jul 2016 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 18 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stop exogenous allergic alveolitis (EAA) or hypersensitivity pneumonitis 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.
Detailed description
After an initial steroid pulse given to all patients, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboCapsules of placebo will be taken for 3 months, same schedule as verum. |
| Prednisolone | Active comparator | Drug: PrednisoloneOral prednisolone, anticipated dose: first month 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. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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:
- Unchanged inhaled steroids if on; if off, no plans to introduce them in the following 6 months
- Agreement to home visit by independent study physician
Key exclusion criteria (6 listed)
- Contraindication for usage systemic steroids
- Critically ill patients needing respiratory support
- Non-compliance with medical treatments and interventions
- 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.
- Pregnancy and lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: no other nameAdminister Placebo as anti-inflammatory | Drug | Placebo |
| PrednisoloneAlso: Decortin HAdminister Prednisolone as anti-inflammatory | Drug | Prednisolone |
Primary outcome
Forced Vital Capacity (FVC).
Time frame: 6 months
The relative change from baseline through month 6 compared to change from placebo of FVC.
1 secondary outcome
Forced Vital Capacity (FVC)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34048641Griese M, Stehling F, Schwerk N, Rosewich M, Jerkic PS, Rock H, Ruckes C, Kronfeld K, Sebah D, Wetzke M, Seidl E. Hypersensitivity pneumonitis: Lessons from a randomized controlled trial in children. Pediatr Pulmonol. 2021 Aug;56(8):2627-2633. doi: 10.1002/ppul.25513. Epub 2021 May 28.
- Individual participant dataSharing planned: No. Equivalent to product information sheet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Griese, Prof., MD study director
Pediatric Pneumology, Ludwig-Maximilians-University Munich
Meike Hengst, MD principal investigator
Pediatric Pneumology, Ludwig-Maximilians University Munich
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisolone in people with Hypersensitivity Pneumonitis and Exogenous Allergic Alveolitis, run by Matthias Griese at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.