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Management of Recurrent Croup

This study has been terminated.
ClinicalTrials.gov Identifier:
First Posted: December 12, 2012
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Brown, University of Michigan
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 Intervention Phase
Croup Drug: Fluticasone Drug: Prednisolone IF needed Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by David Brown, University of Michigan:

Primary Outcome Measures:
  • Quantity of Recurrent Episodes [ Time Frame: 1 year ]
    Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.

Secondary Outcome Measures:
  • 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.)

Enrollment: 10
Study Start Date: September 2012
Study Completion Date: June 2014
Primary Completion Date: June 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.
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


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Ages Eligible for Study:   6 Months to 15 Years   (Child)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748162

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Principal Investigator: David J Brown, MD University of Michigan Department of Otolaryngology-Head & Neck Surgery
  More Information

Additional Information:
Responsible Party: David Brown, Associate Professor of Otorhinolaryngology, University of Michigan
ClinicalTrials.gov Identifier: NCT01748162     History of Changes
Other Study ID Numbers: 00059385
First Submitted: October 31, 2012
First Posted: December 12, 2012
Results First Submitted: October 2, 2017
Results First Posted: November 13, 2017
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by David Brown, University of Michigan:
recurrent croup
barky cough

Additional relevant MeSH terms:
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gastrointestinal Agents
Neuroprotective Agents