Text Size

Management of Recurrent Croup

This study is currently recruiting participants.
Verified December 2012 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
David Brown, University of Michigan
ClinicalTrials.gov Identifier:
NCT01748162
First received: October 31, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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 our 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 Intervention Phase
Croup
 Drug: Fluticasone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Quantity of recurrent episodes [ Time Frame: Quantity of recurrent croup episodes experienced over 1 year period will be measured for each subject. ] [ Designated as safety issue: No ]
    Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.


Secondary Outcome Measures:
  • Severity of croup episodes [ Time Frame: The severity of recurrent croup episodes will be measured over a 1 year period for each particpating subject ] [ Designated as safety issue: No ]
    Severity of recurrent croup episodes based on Westley Croup scale


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: 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.

  Eligibility

Ages Eligible for Study:   6 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748162

Contacts
Contact: Cedric V Pritchett, MD 734-936-9816 cvprit@med.umich.edu
Contact: Shana Lynn 734-763-2877 sylynn@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Shana Lynn     734-763-2877     sylynn@med.umich.edu    
Principal Investigator: David J Brown, MD            
Sub-Investigator: Cedric V Pritchett, MD            
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: David J Brown, MD University of Michigan Department of Otolaryngology-Head & Neck Surgery
Study Director: Cedric V Pritchett, MD University of Michigan Department of Otolaryngology-Head & Neck Surgery
  More Information

Additional Information:
Please visit our Department Facebook page for information regarding the study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: David Brown, Associate Professor of Otorhinolaryngology, University of Michigan
ClinicalTrials.gov Identifier: NCT01748162     History of Changes
Other Study ID Numbers: 00059385
Study First Received: October 31, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
croup
recurrent croup
barky cough

Additional relevant MeSH terms:
Croup
Laryngitis
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Fluticasone
Prednisolone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 23, 2013