Management of Recurrent Croup

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

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
Croup	Drug: Fluticasone; Drug: Prednisolone IF needed	Phase 3

Study Design

• 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

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 [ 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.)

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 15 Years (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, Michigan

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

More Information

Additional Information:

Please visit our Department Facebook page for information regarding the study 

• Responsible Party: David Brown, Associate Professor of Otorhinolaryngology, University of Michigan
• ClinicalTrials.gov Identifier: NCT01748162
• Other Study ID Numbers: 00059385
• First Posted: December 12, 2012
• Results First Posted: November 13, 2017
• Last Update Posted: November 13, 2017
• Last Verified: November 2017

Keywords provided by David Brown, University of Michigan:

croup; recurrent croup; barky cough

Additional relevant MeSH terms:

Laryngitis; Croup; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Fluticasone; Prednisolone; 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; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents