Trial Outcomes & Findings for Stop Exogenous Allergic Alveolitis (EAA) in Childhood (NCT NCT02631603)
NCT ID: NCT02631603
Last Updated: 2024-12-18
Results Overview
The relative change from baseline through month 6 compared to change from placebo of FVC.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
6 months
Results posted on
2024-12-18
Participant Flow
Originally, it was planned to screen 60 subjects to include approximately 40 patients. From January 2015 to July 2016 due to difficulties in funding only 4 children were included in the trial. All met inclusion criteria, were randomized, and completed the trial.
Participant milestones
| Measure |
Placebo
Capsules of placebo will be taken for 3 months.
Placebo: Administer Placebo as anti-inflammatory
|
Prednisolone
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.
Prednisolone: Administer Prednisolone as anti-inflammatory
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stop Exogenous Allergic Alveolitis (EAA) in Childhood
Baseline characteristics by cohort
| Measure |
Prednisolone 1
n=1 Participants
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.
|
Placebo
n=1 Participants
Capsules of placebo will be taken for 3 months.
|
Prednisolone 2
n=1 Participants
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.
|
Prednisolone 3
n=1 Participants
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.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
|
8.4 years
n=5 Participants
|
6.6 years
n=7 Participants
|
10.6 years
n=5 Participants
|
12.9 years
n=4 Participants
|
9.6 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
O2 saturation at rest
|
90 %
n=5 Participants
|
98 %
n=7 Participants
|
100 %
n=5 Participants
|
97 %
n=4 Participants
|
96.3 %
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe relative change from baseline through month 6 compared to change from placebo of FVC.
Outcome measures
| Measure |
Prednisolone 1
n=1 Participants
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.
|
Placebo
n=1 Participants
Capsules of placebo will be taken for 3 months
|
Prednisolone 2
n=1 Participants
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.
|
Prednisolone 3
n=1 Participants
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.
|
|---|---|---|---|---|
|
Forced Vital Capacity (FVC).
|
126 % predicted
|
103 % predicted
|
84 % predicted
|
65 % predicted
|
SECONDARY outcome
Timeframe: 3 monthsFVC measured in accordance to standarized protocol.
Outcome measures
| Measure |
Prednisolone 1
n=1 Participants
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.
|
Placebo
n=1 Participants
Capsules of placebo will be taken for 3 months
|
Prednisolone 2
n=1 Participants
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.
|
Prednisolone 3
n=1 Participants
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.
|
|---|---|---|---|---|
|
Forced Vital Capacity (FVC)
|
114 % predicted
|
95 % predicted
|
85 % predicted
|
76 % predicted
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Prednisolone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=1 participants at risk
Capsules of placebo will be taken for 3 months.
Placebo: Administer Placebo as anti-inflammatory
|
Prednisolone
n=3 participants at risk
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.
Prednisolone: Administer Prednisolone as anti-inflammatory
|
|---|---|---|
|
General disorders
Fever, headache, haematome, tiredness, hypertension
|
100.0%
1/1 • Number of events 2 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
66.7%
2/3 • Number of events 3 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
|
Eye disorders
Conjunctivitis
|
100.0%
1/1 • Number of events 1 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
33.3%
1/3 • Number of events 1 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
|
Infections and infestations
Respiratory tract infection, candidiasis
|
0.00%
0/1 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
66.7%
2/3 • Number of events 2 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
33.3%
1/3 • Number of events 1 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
|
Endocrine disorders
Cushing habitus, hair growth, weight gain
|
100.0%
1/1 • Number of events 1 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
33.3%
1/3 • Number of events 2 • 6 months
The adverse events were collected during the study visits or during the telephone visits.
|
Additional Information
Prof. Dr. med. Matthias Griese
LMU/ Haunersches Kinderspital
Phone: +498944000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place