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

This study has been terminated.
(possibility to discriminate the active drug from placebo)
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00938353
First received: July 10, 2009
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Croup
Drug: beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml
Drug: Placebo solution for nebulisation 2 ml
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • To demonstrate superiority of nebulized BDP vs placebo in Westley croup score at 6 h [ Time Frame: 6 h ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BDP UDV Drug: beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml
Single dose 1600 mcg/4 ml
Placebo Comparator: Placebo Drug: Placebo solution for nebulisation 2 ml
single dose: 4 ml

  Eligibility

Ages Eligible for Study:   6 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938353

Locations
Italy
Ospedale San Giuseppe Moscati
Avellino, Italy, 83100
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
  More Information

No publications provided

Responsible Party: Dr. Gabriele Nicolini, Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00938353     History of Changes
Other Study ID Numbers: MC/PR/1404/003/09, EUDRACT No. 2009-014376-22
Study First Received: July 10, 2009
Last Updated: April 28, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Chiesi Farmaceutici S.p.A.:
Moderate croup (Westley score 3-8)

Additional relevant MeSH terms:
Croup
Laryngitis
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 20, 2014