Trial Outcomes & Findings for Management of Recurrent Croup (NCT NCT01748162)

Results Overview

Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

10 participants

Primary outcome timeframe

1 year

Results posted on

2017-11-13

Participant Flow

10 participants were recruited and consented and had their initial baseline bronchoscopy, but of the 5 at 1 site, only 1 had an actual croup episode within he first 6 months. Because of decreased recruitment, the study was terminated. The other site's data is not fully available due to unexpected staff turnover and systems failures.

Participant milestones

Participant milestones
Measure	Inhaled Steroids Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.	Oral Control Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
Overall Study STARTED	5	5
Overall Study Started 6 Month Initial Treatment Plan	2	2
Overall Study Completed 6 Month Initial Treatment	0	0
Overall Study Started 6 Month Followup	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Inhaled Steroids Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.	Oral Control Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
Overall Study no additional croup episodes to evaluate	2	2
Overall Study participant consented but did not begin	0	1
Overall Study reasons not available	3	2

Baseline Characteristics

Due to unexpected staff turnover, data from one site is incomplete.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inhaled Steroids n=5 Participants Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.	Oral Control n=5 Participants Short term oral prednisolone. Offered at 1mg/kg daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.	Total n=10 Participants Total of all reporting groups
Age, Customized 6 months to 15 years	5 Participants n=5 Participants	5 Participants n=5 Participants	10 Participants n=10 Participants
Sex: Female, Male Female	0 Participants n=2 Participants • Due to unexpected staff turnover, data from one site is incomplete.	2 Participants n=3 Participants • Due to unexpected staff turnover, data from one site is incomplete.	2 Participants n=5 Participants • Due to unexpected staff turnover, data from one site is incomplete.
Sex: Female, Male Male	2 Participants n=2 Participants • Due to unexpected staff turnover, data from one site is incomplete.	1 Participants n=3 Participants • Due to unexpected staff turnover, data from one site is incomplete.	3 Participants n=5 Participants • Due to unexpected staff turnover, data from one site is incomplete.
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=5 Participants	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: 1 year

Population: No participants completed to 1 year because of early study termination.

Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: No participants completed to 1 year because of early study termination.

Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.)

Outcome measures

Outcome data not reported

Adverse Events

Inhaled Steroids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Control

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

Dr. David J. Brown

University of Michigan

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place