Management of Recurrent Croup

Sponsor
University of Michigan (Other)
Overall Status
Terminated
CT.gov ID
NCT01748162
Collaborator
(none)
10
1
2
21
0.5

Study Details

Study Description

Brief Summary

Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Inhaled steroids

Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.

Drug: Fluticasone
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.

Active Comparator: Oral control

Patient and clinician observation with short term oral prednisolone as needed. Offered at 1mg/kg (body weight) daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.

Drug: Prednisolone IF needed

Outcome Measures

Primary Outcome Measures

  1. Quantity of Recurrent Episodes [1 year]

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

Secondary Outcome Measures

  1. Severity of Croup Episodes [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pediatric population: 6 months to 15 years of age

  • 2 or more episodes of croup in 12 month period

  • croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress.

Exclusion Criteria:
  • Grade 3 or 4 subglottic stenosis

  • Subglottic hemangioma

  • Posterior laryngeal cleft

  • Recurrent respiratory papillomatosis

  • External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc)

  • Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body

  • Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress

  • Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease.

  • Other medical conditions necessitating chronic steroid utilization

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: David J Brown, MD, University of Michigan Department of Otolaryngology-Head & Neck Surgery

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
David Brown, Associate Professor of Otorhinolaryngology, University of Michigan
ClinicalTrials.gov Identifier:
NCT01748162
Other Study ID Numbers:
  • 00059385
First Posted:
Dec 12, 2012
Last Update Posted:
Nov 13, 2017
Last Verified:
Nov 1, 2017
Keywords provided by David Brown, Associate Professor of Otorhinolaryngology, University of Michigan
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details 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.
Pre-assignment Detail
Arm/Group Title Inhaled Steroids Oral Control
Arm/Group Description 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. 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.
Period Title: Overall Study
STARTED 5 5
Started 6 Month Initial Treatment Plan 2 2
Completed 6 Month Initial Treatment 0 0
Started 6 Month Followup 0 0
COMPLETED 0 0
NOT COMPLETED 5 5

Baseline Characteristics

Arm/Group Title Inhaled Steroids Oral Control Total
Arm/Group Description 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. 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 of all reporting groups
Overall Participants 5 5 10
Age, Customized (Count of Participants)
6 months to 15 years
5
100%
5
100%
10
100%
Sex: Female, Male (Count of Participants)
Female
0
0%
2
40%
2
20%
Male
2
40%
1
20%
3
30%
Region of Enrollment (Count of Participants)
United States
5
100%
5
100%
10
100%

Outcome Measures

1. Primary Outcome
Title Quantity of Recurrent Episodes
Description Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
No participants completed to 1 year because of early study termination.
Arm/Group Title Inhaled Steroids Oral Control
Arm/Group Description 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. 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.
Measure Participants 0 0
2. Secondary Outcome
Title Severity of Croup Episodes
Description Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.)
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
No participants completed to 1 year because of early study termination.
Arm/Group Title Inhaled Steroids Oral Control
Arm/Group Description 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. 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.
Measure Participants 0 0

Adverse Events

Time Frame Six months (because study was terminated based on no participants having additional episodes).
Adverse Event Reporting Description
Arm/Group Title Inhaled Steroids Oral Control
Arm/Group Description 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. 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.
All Cause Mortality
Inhaled Steroids Oral Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Inhaled Steroids Oral Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/5 (0%) 0/5 (0%)
Other (Not Including Serious) Adverse Events
Inhaled Steroids Oral Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/5 (0%) 0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. David J. Brown
Organization University of Michigan
Phone
Email davidjb@med.umich.edu
Responsible Party:
David Brown, Associate Professor of Otorhinolaryngology, University of Michigan
ClinicalTrials.gov Identifier:
NCT01748162
Other Study ID Numbers:
  • 00059385
First Posted:
Dec 12, 2012
Last Update Posted:
Nov 13, 2017
Last Verified:
Nov 1, 2017