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A double-blind, randomized, double dummy, cross over, study to assess the difference in efficacy between nebulisation of rhDNase before airway clearande therapy (ACT)versus nebulisation after ACT.


- candidate number1550
- NTR NumberNTR352
- ISRCTNISRCTN87248226
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleA double-blind, randomized, double dummy, cross over, study to assess the difference in efficacy between nebulisation of rhDNase before airway clearande therapy (ACT)versus nebulisation after ACT.
- Scientific TitleA double-blind, randomized, double dummy, cross over, study to assess the difference in efficacy between nebulisation of rhDNase before airway clearande therapy (ACT)versus nebulisation after ACT.
- ACRONYMN/A
- hypothesisInhalation of rhDNase after airway clearande therapy (ACT) increases the expiratory flow at 25% of the actual forced vital capacity (MEF25) compared to inhalation of rhDNase before ACT.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF)
- Inclusion criteria1. 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
a. Five years or older;
b. Able to perform reproducible manoeuvres for spirometry;
c. Carrying out daily CPT;
d. Maintenance treatment with rhDNase for at least one month;
e. Clinically stable for at least one month (no intravenous antibiotics and / or hospitalizations within one month before enrolment);
4. 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.
- Exclusion criteria1. Using rhDNase more than once daily;
2. Mental retardation;
3. Having a history of non-adherence to treatment advice known to the physician.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2003
- planned closingdate1-jul-2004
- Target number of participants25
- InterventionsThe study was a randomized, 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 randomized 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. (Figure 1)
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.
- Primary outcomePulmonary function tests: MEF25.
- Secondary outcome1. Pulmonary function tests: FVC, FEV1, Rint;
2. Severity of cough with a VCD score;
3. Sputum characteristics: amount, viscosity with a VAS-score.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Lianne Giessen, van der
- CONTACT for SCIENTIFIC QUERIES Lianne Giessen, van der
- Sponsor/Initiator Roche Nederland BV
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV
- PublicationsPediatr Pulmonol. 2007 Jul;42(7):624-30.

Eur Respir J. 2007 Oct;30(4):763-8. Epub 2007 Jun 27.
- Brief summaryIntroduction:
Though the effectiveness of rhDNase is well established, little research has been carried out to determine the optimal time relation between rhDNase and ACT.
Objective:
To assess the difference in lung function between nebulisation of rhDNase before ACT versus nebulisation after ACT.
Methods:
The study was a randomized, double blind, double dummy, cross over design. Inclusion criteria were CF, stable clinical condition and rhDNase maintenance therapy.
Randomisation:
- Group I: Week 1-3, inhalation of rhDNase 30 minutes before, and placebo directly after ACT. The reversed protocol was performed during week 4-6.
- Group II: Reversed sequence. Patients continued their daily routine ACT.
Primary endpoint:
MEF25. Flow volume manoeuvre and Rinte were measured on day 0, 14, 21, 35 and 42. The children scored cough and sputum production daily on diary cards in week 3 and 6.
- Main changes (audit trail)
- RECORD12-sep-2005 - 16-jun-2008


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