Management of Recurrent Croup

NCT01748162 | Terminated Phase 3 Results

• 1 other identifier: 00059385
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Croup

Keywords

croup; recurrent croup; barky cough

Outcome Measures

Primary Outcomes (1)

• Quantity of Recurrent Episodes

  Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.

  1 year

Secondary Outcomes (1)

• Severity of Croup Episodes

  1 year

Study Arms (2)

Inhaled steroids

EXPERIMENTAL

Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.

Drug: Fluticasone

Oral control

ACTIVE COMPARATOR

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

Interventions

Fluticasone DRUG

Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.

Inhaled steroids

Prednisolone IF needed DRUG

Oral control

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric population: 6 months to 15 years of age
• or more episodes of croup in 12 month period
• croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Links

• Please visit our Department Facebook page for information regarding the study

MeSH Terms

Conditions

Croup

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Laryngitis; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. David J. Brown
• Organization: University of Michigan

davidjb@med.umich.edu

Study Officials

• David J Brown, MD

  University of Michigan Department of Otolaryngology-Head & Neck Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otorhinolaryngology

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: December 12, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 13, 2017
• Results First Posted: November 13, 2017

Record last verified: 2017-11

Locations

US (1)