A double-blind, randomised, double dummy, cross-over, study to assess the difference in efficacy between nebulisation of rhDNase in the morning versus nebulisation before going to sleep

Not Applicable

Completed

• Conditions: Cystic fibrosis; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN74815264
• Lead Sponsor: Roche Nederland BV (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Proven cystic fibrosis (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 Medical Centre - Sophia
3. Five years and older
4. Able to perform reproducible manoeuvres for spirometry
5. Maintenance treatment with rhDNase for at least one month
6. Clinically stable for at least one month (no intravenous antibiotics and/or hospitalisations within one month before enrolment)
7. Willing to participate in and comply with study procedures, and willingness of the parent or guardian and subjects greater than 12 years to provide written informed consent

Exclusion Criteria

1. Forced vital capacity (FVC) less than 40%
2. Using rhDNase more than once daily
3. Mentally retarded
4. History of non-adherence to treatment advice known to the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary function test: MEF25

Secondary Outcome Measures

Name	Time	Method
1. Pulmonary function tests: FVC, forced expiratory volume in one second (FEV1), Rint<br>2. Frequency and duration of coughing measured with audio recording<br>3. Oxygenation at night recording transcutaneous oxygen saturation; percentage with saturation below 95%<br>4. Severity of cough with a verbal category descriptive (VCD) score<br>5. Sputum characteristics: amount, viscosity with a visual analogue scale (VAS) score<br>6. Quality of sleep and appetite with a VAS score<br>7. Presence of morning sickness