Contact information
Type
Scientific
Primary contact
Dr H.A.W.M. Tiddens
ORCID ID
Contact details
Erasmus Medical Center
Sophia Childrens Hospital Rotterdam
Department of Pediatric Pulmonology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636690
h.tiddens@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2412325-2
Study information
Scientific title
Acronym
IDOL
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Obstructive pulmonary function, asthma
Intervention
Nebulization with rhDNase or placebo once daily (each participant is treated for two weeks with rhDNase and for 2 weeks with placebo)
Intervention type
Drug
Phase
Not Specified
Drug names
Recombinant human deoxyribonuclease (rhDNase)
Primary outcome measures
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.
Secondary outcome measures
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)
Overall trial start date
01/09/2006
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60
Participant exclusion criteria
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
Recruitment start date
01/09/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
Funders
Funder type
Industry
Funder name
Roche Nederland BV
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