Management of Recurrent Croup

November 1, 2017 updated by: David Brown, University of Michigan

Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Croup Episodes
Time Frame: 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.)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00059385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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