Efficacy of peripherally targeted inhaled rhDNase for persistent obstructive asthma in childhood
ISRCTN | ISRCTN71537084 |
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DOI | https://doi.org/10.1186/ISRCTN71537084 |
EudraCT/CTIS number | 2006-002337-20 |
Secondary identifying numbers | 2412325-2, NL612, NTR671 |
- Submission date
- 09/06/2006
- Registration date
- 09/06/2006
- Last edited
- 08/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H.A.W.M. Tiddens
Scientific
Scientific
Erasmus Medical Center
Sophia Childrens Hospital Rotterdam
Department of Pediatric Pulmonology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
Phone | +31 (0)10 4636690 |
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h.tiddens@erasmusmc.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | Efficacy of peripherally targeted inhaled rhDNase for persistent obstructive asthma in childhood |
Study acronym | IDOL |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Recombinant human deoxyribonuclease (rhDNase) |
Primary outcome measure | 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 study start date | 01/09/2006 |
Completion date | 01/01/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 6 Years |
Upper age limit | 18 Years |
Sex | Both |
Target number of participants | 60 |
Total final enrolment | 64 |
Key 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) |
Key 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 |
Date of first enrolment | 01/09/2006 |
Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
University/education
University/education
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
https://ror.org/018906e22 |
Funders
Funder type
Industry
Roche Nederland BV
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/08/2013 | 08/01/2021 | Yes | No |
Editorial Notes
08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
4. The EudraCT number has been added.