Trial Outcomes & Findings for Preschool Wheeze: Inflammation/Infection Guided Management (NCT NCT02517099)
NCT ID: NCT02517099
Last Updated: 2023-03-06
Results Overview
Actual number of unscheduled healthcare visits (UHCV) includes GP, A\&E or hospital admission. This is median number of visits in 4 months - with range.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
4 months
Results posted on
2023-03-06
Participant Flow
Participant milestones
| Measure |
Pathological Phenotype
Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
Clinical Guidelines
The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preschool Wheeze: Inflammation/Infection Guided Management
Baseline characteristics by cohort
| Measure |
Pathological Phenotype
n=30 Participants
Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
Clinical Guidelines
n=30 Participants
The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
60 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
54 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Region of Enrollment
United Kingdom
|
30 participants
n=39 Participants
|
30 participants
n=41 Participants
|
60 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: 8 patients failed to attend follow up at 4 months
Actual number of unscheduled healthcare visits (UHCV) includes GP, A\&E or hospital admission. This is median number of visits in 4 months - with range.
Outcome measures
| Measure |
Pathological Phenotype
n=25 Participants
Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
Clinical Guidelines
n=27 Participants
The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
|---|---|---|
|
Number of Unscheduled Healthcare Visits (UHCV)
|
0.5 number of visits
Interval 0.0 to 7.0
|
0.5 number of visits
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 8 patients failed to attend for 4 month follow up
Quality of life assessed using the Paediatric Caregivers Asthma Quality of Life Questionnaire (PACQLQ). The scores are from 1.0-7.0, higher value is a better outcome. We calculated the actual score at baseline and at 4 months. A change in score of 0.5 is considered clinically significant. We recorded actual value at baseline and actual value at 4 months.
Outcome measures
| Measure |
Pathological Phenotype
n=25 Participants
Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
Clinical Guidelines
n=27 Participants
The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
|---|---|---|
|
Health Related Quality of Life
|
6.7 score on a scale
Interval 1.5 to 7.0
|
6.4 score on a scale
Interval 2.4 to 7.0
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 8 patients failed to attend for 4 month follow up
Number of days with symptoms during 4 months
Outcome measures
| Measure |
Pathological Phenotype
n=25 Participants
Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
Clinical Guidelines
n=27 Participants
The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
|---|---|---|
|
Symptom Days
|
9 days
Interval 0.0 to 45.0
|
12 days
Interval 0.0 to 49.0
|
SECONDARY outcome
Timeframe: 4 months and up to 1 year laterPopulation: 8 patients failed to attend for 4 month follow up
Number of steroid courses needed during 4 months for any acute symptoms.
Outcome measures
| Measure |
Pathological Phenotype
n=25 Participants
Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
Clinical Guidelines
n=27 Participants
The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
Beclometasone: Beclometasone dipropionate 200mcg bd for 4 months
Co-amoxiclav: Co-amoxiclav 0.3ml/kg bd for 4 weeks
Azithromycin: Azithromycin 10mg/kg od for 4 weeks
|
|---|---|---|
|
Number of Courses of Oral Steroids
|
13 number of steroid courses
|
14 number of steroid courses
|
Adverse Events
Pathological Phenotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinical Guidelines
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place