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Efficacy of inhaled rhDNase for acute asthma in childhood.


- candidate number1419
- NTR NumberNTR240
- ISRCTNISRCTN81874766
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsN/A 
- Public TitleEfficacy of inhaled rhDNase for acute asthma in childhood.
- Scientific TitleEfficacy of inhaled rhDNase for acute asthma in childhood.
- ACRONYMN/A
- hypothesisWe hypothesize 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.
- Healt Condition(s) or Problem(s) studiedAcute asthma
- Inclusion criteriaChildren, aged 2-18 years, with acute asthma who require at least two doses of bronchodilators at the emergency department.
- Exclusion criteria1. Dyspnoea due to other causes than asthma;
2. Patients with a concurrent chronic pulmonary disease, such as CF, BPD;
3. Patients with a symptomatic cardial or neuromuscular disease.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2005
- planned closingdate15-sep-2007
- Target number of participants100
- InterventionsOne dose of 5 mg DNase OR one dose of 5 mg placebo in addition to standard care.
- Primary outcomeImprovement in asthma score 1 hour after intervention.
- Secondary outcome1. Need for hospital admission;
2. Duration of hosptial 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. R. Boogaard
- CONTACT for SCIENTIFIC QUERIESMD. R. Boogaard
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD6-sep-2005 - 5-jan-2010


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