Efficacy of inhaled rhDNase for acute asthma in childhood

ISRCTN	ISRCTN81874766
DOI	https://doi.org/10.1186/ISRCTN81874766
Protocol serial number	NTR240
Sponsor	Erasmus Medical Centre (Netherlands)
Funder	Roche Nederland BV (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr R Boogaard
Scientific

Erasmus Medical Centre
Sophia Childrens Hospital
Department of Pediatric Pulmonology, SB-2666
P.O. Box 2060
Rotterdam
3000 CB
Netherlands

Phone	+31 (0)10 463 6683
Email	r.boogaard@erasmusmc.nl

Primary study design	Interventional
Study design	Multicentre randomised double-blind placebo-controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	We hypothesise that rhDNase can liquefy sputum in acute asthma resulting in less airways obstruction, reduced work of breathing, and diminished ventilation-perfusion mismatch, thereby improving symptoms, reducing the number of patients who need to be admitted, and shorten the duration of admission.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Acute Asthma
Intervention	One dose of 5 mg rhDNase or one dose of 5 mg placebo in addition to standard care.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	rhDNase
Primary outcome measure(s)	Improvement in asthma score 1 hour after intervention.
Key secondary outcome measure(s)	1. Need for hospital admission 2. Duration of hospital admission 3. Asthma score at 2, 6, 12 and 24 hours after intervention 4. Heart rate, respiratory rate and oxygen saturation 5. Need for additional oxygen 6. Number of bronchodilators 7. Doctors visit or readmission and use of rescue bronchodilator aerosol therapy following 72 hours after discharge from EMD 8. Cost-consequence analysis
Completion date	15/09/2007

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	Children, aged 2 - 18 years, with acute asthma who require at least two doses of bronchodilators at the Emergency Department.
Key exclusion criteria	1. Dyspnoea due to other causes than asthma 2. Patients with a concurrent chronic pulmonary disease, such as cystic fibrosis (CF), bronchopulmonary dysplasia (BPD) 3. Patients with a symptomatic cardial or neuromuscular disease
Date of first enrolment	15/09/2005
Date of final enrolment	15/09/2007

Erasmus Medical Centre

Rotterdam
3000 CB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan