Efficacy of Nebulized Beclomethasone Dipropionate (BDP) in the Treatment of Moderate Croup

NCT ID: NCT00938353

Last Updated: 2011-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-09-30

Brief Summary

Acute laryngotracheobronchitis, better known as croup, is one of the common respiratory complaints among children and the most common cause of airway obstruction in children aged six months to six years. Patients with croup are typically visited by physicians during two peak time periods throughout the year. The first one is in the autumn, usually as a result of parainfluenza virus, and the second peak occurs in early winter, a consequence of RSV. Croup affects males more commonly than females and affects children between the ages of 6 months to 6 years. The incidence of croup peaks in children at 2 years of age; croup in older children is uncommon, and recurrent episodes are frequently observed.

Croup symptoms are generally short-lived, with about 60% of children showing resolution of their barky cough within 48 h. However, a few children continue to have symptoms for up to 1 week. Although most children with croup recover without specific treatment, up to 15% require hospital admission, and, among those admitted, up to 5% may require intubation.

Nebulised adrenaline is effective but it has a short duration of action and potentially dangerous side effects, and it is therefore not recommended for use in the community in mild-moderate Croup.

Oral and intramuscular steroid treatment, when given in adequate doses in hospital, has been shown to be effective for moderate to severe croup in a number of trials and a meta analysis.

It has been suggested that nebulised administration is superior to the oral or intramuscular route of administration for a more rapid onset of action and fewer side-effects.

This study is aimed to demonstrate the effectiveness of nebulised steroid administration as beclomethasone dipropionate in croup patients compare to placebo.

Conditions

Croup

Keywords

Moderate croup (Westley score 3-8)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BDP UDV

Group Type: EXPERIMENTAL

beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml

Intervention Type: DRUG

Single dose 1600 mcg/4 ml

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo solution for nebulisation 2 ml

Intervention Type: DRUG

single dose: 4 ml

Interventions

beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml

Single dose 1600 mcg/4 ml

Intervention Type: DRUG

Placebo solution for nebulisation 2 ml

single dose: 4 ml

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written informed consent obtained by parents/legal representative prior to any study-related procedures.

2. Male or female subject aged between 6 months and 3 years referring to ER with acute onset barky cough, stridor, hoarseness, and respiratory distress

3. Children with a diagnosis of moderate croup (Westley score 3-8)

Exclusion Criteria

1. Symptoms or signs of any other cause of stridor;

2. Previous acute angioneurotic oedema;

3. Children with diagnosis of severe croup (Wesley score >8);

4. History of congenital or acquired stridor, diagnosis of epiglottitis, chronic pulmonary disease, asthma, severe systemic disease, exposure to chickenpox virus within the previous 21 days, or known immune dysfunction;

5. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study;

6. Treatment with oral or parenteral corticosteroids within the previous 2 weeks; Treatment with epinephrine for respiratory distress before enrollment;

7. Previous visit to an emergency room department due to croup during this episode of the disease;

8. Inability of the parent to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments;

9. Enrollment in another clinical trial in the previous 4 weeks or subject already admitted in this study

10. Lack of a telephone at home;

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Chiesi Farmaceutici S.p.A.

Locations

Ospedale San Giuseppe Moscati

Avellino, , Italy

Countries

Italy

Other Identifiers

EUDRACT No. 2009-014376-22

Identifier Type: -

Identifier Source: secondary_id

MC/PR/1404/003/09

Identifier Type: -

Identifier Source: org_study_id