No registrations found.
ID
Source
Brief title
Health condition
Cysic Fibrosis.
Sponsors and support
PO box 44
3440 AA WOERDEN
The Netherlands
Intervention
Outcome measures
Primary outcome
Pulmonary function tests: MEF25.
Secondary outcome
1. Pulmonary function tests: FVC, FEV1, Rint;
2. Severity of cough with a VCD score;
3. Sputum characteristics: amount, viscosity with a VAS-score.
Background summary
Introduction:
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.
Study objective
Inhalation 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.
Study design
N/A
Intervention
The 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.
Dr Molewaterplein 60
Lianne Giessen, van der
Dr Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636764
L.vandergiessen@erasmusmc.nl
Dr Molewaterplein 60
Lianne Giessen, van der
Dr Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636764
L.vandergiessen@erasmusmc.nl
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
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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL314 |
| NTR-old | NTR352 |
| Other | : N/A |
| ISRCTN | ISRCTN87248226 |
Summary results
<br><br>
Eur Respir J. 2007 Oct;30(4):763-8. Epub 2007 Jun 27.<br>