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

Multicentre, Randomized, Double-blind, Placebo-controlled, Two-arm Parallel Groups Study Design to Demonstrate the Efficacy and Tolerability of a Single Dose of BDP Suspension for Nebulisation 1600 µg vs Placebo in the Treatment of Children Aged 6 Months to 3 Years With a Clinical Diagnosis of Moderate Croup

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.

Study Overview

• Status: Terminated
• Conditions: Croup
• Intervention / Treatment: Drug: beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml; Drug: Placebo solution for nebulisation 2 ml

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Avellino, Italy, 83100
    • Ospedale San Giuseppe Moscati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo solution for nebulisation 2 ml; single dose: 4 ml
Experimental: BDP UDV	Drug: beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml; Single dose 1600 mcg/4 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To demonstrate superiority of nebulized BDP vs placebo in Westley croup score at 6 h	6 h

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): April 29, 2011
• Last Update Submitted That Met QC Criteria: April 28, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Moderate croup (Westley score 3-8)
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Laryngitis; Croup; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone
• Other Study ID Numbers: MC/PR/1404/003/09; EUDRACT No. 2009-014376-22