Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Management of Recurrent Croup

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. Identifier: NCT01748162
Recruitment Status : Terminated
First Posted : December 12, 2012
Results First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Information provided by (Responsible Party):
David Brown, University of Michigan

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
Croup Drug: Fluticasone Drug: Prednisolone IF needed Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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

Primary Outcome Measures :
  1. 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 :
  1. 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.)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT01748162

Layout table for location information
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Layout table for investigator information
Principal Investigator: David J Brown, MD University of Michigan Department of Otolaryngology-Head & Neck Surgery
Additional Information:
Layout table for additonal information
Responsible Party: David Brown, Associate Professor of Otorhinolaryngology, University of Michigan Identifier: NCT01748162    
Other Study ID Numbers: 00059385
First Posted: December 12, 2012    Key Record Dates
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:
Layout table for MeSH terms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Infections
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