Condition category
Respiratory
Date applied
09/06/2006
Date assigned
09/06/2006
Last edited
11/09/2006
Prospective/Retrospective
Prospectively 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 H.A.W.M. Tiddens

ORCID ID

Contact details

Erasmus Medical Center
Sophia Children’s 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

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes