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ISRCTN
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ISRCTN71537084
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ClinicalTrials.gov identifier
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Public title
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Efficacy of peripherally targeted inhaled rhDNase for persistent obstructive asthma in childhood
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Scientific title
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Acronym
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IDOL
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Serial number at source
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2412325-2
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Study hypothesis
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Recombinant human deoxyribonuclease (rhDNase) improves lung function in children with persistent asthma who have persistent obstructive pulmonary function.
Treatment of mucus impaction is an interesting alternative approach to treating peripheral airflow limitation in asthmatic patients. In severe asthma, dramatic improvement has been described in a few patients after inhalation of the mucolytic rhDNase. In addition, in pathology studies, extensive mucus plugging has been described in asthmatic patients. Based on these findings we think that additional treatment benefit can be obtained when mucus plugging is targeted as part of asthma treatment. Especially for those asthmatic children with persistent peripheral airways obstruction, rhDNase is a well known and safe drug that could be used for this treatment. Therefore we hypothesise that rhDNase has additional effect on lung function in children with persistent asthma who have persistent obstructive pulmonary function.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Obstructive pulmonary function, asthma
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Participants - inclusion criteria
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1. Aged 6 - 18 years
2. Asthma diagnosed according to Global Initiative For Asthma (GINA) guidelines
3. Attending the outpatient clinic for at least one year
4.Treatment with at least 400 mg/day inhaled budesonide or equivalent (dose constant for at least 6 months) and bronchodilators as needed or daily
5. Clinically stable asthma while using a constant dose of Inhaled Corticosteroid (ICS) for at least three months
6. Ability to perform lung function tests (assessed by trained lung function technician)
7. Persistent peripheral airways obstruction as assessed by pulmonary function testing, defined as: dissociation between forced vital capacity (FVC) and FEF75 values: FEF75 at least 20% (absolute % predicted) lower than FVC (FEF = Forced Expiratory Flow rate)
8. FVC within normal limits (for this study defined as FVC >80% predicted)
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Participants - exclusion criteria
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1. Asthma exacerbation with hospital admission in last three months
2. Intensive care unit (ICU) admission for asthma within the last year
3. Current respiratory tract infection
4. Inability to follow instructions of the investigator
5. Inability to inhale rhDNase
6. Concomitant medical conditions that can affect inhaled treatment (e.g. cleft palate, severe malacia)
7. Neuromuscular disease
8. Smoking
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Anticipated start date
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01/09/2006
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Anticipated end date
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01/01/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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Nebulization with rhDNase or placebo once daily (each participant is treated for two weeks with rhDNase and for 2 weeks with placebo)
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Primary outcome measure(s)
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Primary endpoint will be the change in FEF75 as a result of treatment. FEF75 is the most suitable endpoint since it is sensitive to peripheral airways obstruction.
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Secondary outcome measure(s)
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Secondary endpoints will include:
1. Lung clearance index (LCI) measurements as assessed by multiple breath washout
2. Cumulative symptom diary scores evaluating asthma symptoms in the second week of intervention (e.g. shortness of breath, cough, exercise intolerance, bronchodilator use etc.);
3. Fraction of exhaled nitric oxide (FENO)
4. Other values obtained in the flow volume curve: FEV1, FVC, peak expiratory flow (PEF)
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Sources of funding
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Roche Nederland BV
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Trial website
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Publications
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Contact name
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Dr
H.A.W.M.
Tiddens
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Address
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Erasmus Medical Center
Sophia Children’s Hospital Rotterdam
Department of Pediatric Pulmonology
Dr. Molewaterplein 60
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City/town
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Rotterdam
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Zip/Postcode
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3015 GJ
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Country
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Netherlands
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Tel
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+31 (0)10 4636690
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Fax
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+31 (0)10 4636801
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Email
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h.tiddens@erasmusmc.nl
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Sponsor
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Erasmus Medical Center (The Netherlands)
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Address
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P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Date applied
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09/06/2006
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Last edited
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11/09/2006
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Date ISRCTN assigned
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09/06/2006
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