Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
24/08/2009
Prospective/Retrospective
Retrospectively 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 Lianne Giessen, van der

ORCID ID

Contact details

Erasmus Medical Center
Sophia Children's Hospital
Department Pediatric Physiotherapy
SK 0327
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636764
L.vandergiessen@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR352

Study information

Scientific title

Acronym

Study hypothesis

Inhalation of rhDNase after airway clearance therapy (ACT) increases the expiratory flow at 25% of the actual forced vital capacity (MEF25) compared to inhalation of rhDNase before ACT.

Ethics approval

Received from local medical ethics committee

Study design

Randomised double blind double dummy placebo controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cystic Fibrosis (CF)

Intervention

The study was a randomised, double blind, double dummy, cross over design. All subjects nebulized daily both rhDNase (2.5 mg of rhDNase in 2.5 ml buffered solution: 8.77 mg/ml sodium chloride and 0.15 mg/ml calcium chloride) and a placebo (2.5 ml of a buffered solution: 8.77 mg/ml sodium chloride and 0.15 mg/ml calcium chloride) once daily for a period of six weeks.
Placebo was similar to rhDNase in both color and taste.
Subjects were randomised to two groups:
Group I used rhDNase 30 minutes before ACT and placebo directly after ACT in the first three weeks. In the following three weeks rhDNase and placebo were taken in reversed order.
Group II used placebo 30 minutes before ACT and rhDNase after ACT in the first three weeks. In the following three weeks placebo and rhDNase were taken in reversed order.
Patients were asked to carry out their daily routine ACT and not to change their routine technique. The timing during the day of nebulisation and ACT were kept constant throughout the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pulmonary function tests: MEF25

Secondary outcome measures

1. Pulmonary function tests:
1.1. Forced vital capacity (FVC)
1.2. Forced expiratory volume in one second (FEV1)
1.3. Rint
2. Severity of cough with a VCD score
3. Sputum characteristics: amount, viscosity with a visual analogue scale (VAS)

Overall trial start date

01/08/2003

Overall trial end date

01/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Proven CF, as evidenced by an abnormal sweat test or an abnormal rectum potential difference measurement or by the presence of two CF mutations and at least one clinical feature of CF
2. Treated at the Erasmus MC - Sophia, and:
2.1. Five years or older
2.2. Able to perform reproducible manoeuvres for spirometry
2.3. Carrying out daily CPT
2.4. Maintenance treatment with rhDNase for at least one month
2.5. Clinically stable for at least one month (no intravenous antibiotics and/or hospitalisations within one month before enrolment)
3. Willing to participate in and comply with study procedures, and willingness of the parent or guardian and of the subjects >12 years to provide written informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Using rhDNase more than once daily
2. Mental retardation
3. Having a history of non-adherence to treatment advice known to the physician

Recruitment start date

01/08/2003

Recruitment end date

01/07/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands

Sponsor information

Organisation

Roche Nederland BV (Netherlands)

Sponsor details

P.O. Box 44
Woerden
3440 AA
Netherlands

Sponsor type

Industry

Website

http://www.roche.nl

Funders

Funder type

Industry

Funder name

Roche Nederland BV (Netherlands)

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17534979

Publication citations

  1. Results

    van der Giessen LJ, de Jongste JC, Gosselink R, Hop WC, Tiddens HA, RhDNase before airway clearance therapy improves airway patency in children with CF., Pediatr. Pulmonol., 2007, 42, 7, 624-630, doi: 10.1002/ppul.20636.

Additional files

Editorial Notes