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Management of Recurrent Croup

NCT ID: NCT01748162

Last Updated: 2017-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Croup

Keywords

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croup recurrent croup barky cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inhaled steroids

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

Group Type EXPERIMENTAL

Fluticasone

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Prednisolone IF needed

Intervention Type DRUG

Interventions

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Fluticasone

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

Intervention Type DRUG

Prednisolone IF needed

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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David Brown

Associate Professor of Otorhinolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David J Brown, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Department of Otolaryngology-Head & Neck Surgery

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Related Links

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http://www.facebook.com/MichiganOtolaryngology

Please visit our Department Facebook page for information regarding the study

Other Identifiers

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00059385

Identifier Type: -

Identifier Source: org_study_id