Management of Recurrent Croup

Croup Clinical Trial

Official title:

Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01748162
• Other study ID #: 00059385
• Status: Terminated
• Phase: Phase 3
• First received: October 31, 2012
• Last updated: November 1, 2017
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Croup

Intervention

Drug:
• Fluticasone
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
• Prednisolone IF needed

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of Recurrent Episodes	Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.	1 year
Secondary	Severity of Croup Episodes	Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.)	1 year

External Links

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