Study to look at the usefulness of an extra dose of salbutamol (medicine that widens the airways in the lungs) through the bloodstream, in children who are admitted to an intensive care for a very severe asthma-attack.

Phase 1

• Conditions: Severe acute (viral) wheeze and severe acute asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; MedDRA version: 19.0Level: LLTClassification code 10047921Term: WheezeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 19.0Level: PTClassification code 10041961Term: Status asthmaticusSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2015-003551-22-NL
• Lead Sponsor: Erasmus MC - Sophia Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-27
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Between 2-18 years of age at moment of inclusion
-Admitted to PICU for Severe Acute Asthma or Severe acute (viral) wheeze
-Requiring administration of IV salbutamol

Are the trial subjects under 18? yes
Number of subjects for this age range: 52
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patient is outside of specified age range
-Patient has already received a -loading dose- of IV salbutamol in the general hospital
-Lower airway infection with consolidation on a chest X ray
-Patient has Down’s Syndrome
-Patient has a congenital/acquired heart defect that interferes with normal asthma treatment
-Patient has a primary/secondary immunodeficiency
-Patient has a pre-existing chronic pulmonary condition, known to mimic asthma: Cystic fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified