Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R Boogaard

ORCID ID

Contact details

Erasmus Medical Centre
Sophia Children’s Hospital
Department of Pediatric Pulmonology
SB-2666
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 463 6683
r.boogaard@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR240

Study information

Scientific title

Acronym

Study hypothesis

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

Received from the local medical ethics committee

Study design

Multicentre randomised double-blind placebo-controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

rhDNase

Primary outcome measures

Improvement in asthma score 1 hour after intervention.

Secondary outcome measures

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. Doctor’s visit or readmission and use of rescue bronchodilator aerosol therapy following 72 hours after discharge from EMD
8. Cost-consequence analysis

Overall trial start date

15/09/2005

Overall trial end date

15/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Children, aged 2 - 18 years, with acute asthma who require at least two doses of bronchodilators at the Emergency Department.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

15/09/2005

Recruitment end date

15/09/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 CB
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Industry

Funder name

Roche Nederland BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes