Should Any One Airway Clearance Technique be Recommended for People With Cystic Fibrosis?
Phase 4
Completed
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00890370
- Lead Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Brief Summary
The study was to evaluate the long term effects, over one year, of five airway clearance techniques used by people with cystic fibrosis (active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure (R-C Cornet and Flutter)). The primary outcome measure was forced expiratory volume in one second (FEV1)and the null hypothesis was that there are no differences among the regimens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
- Diagnosis of cystic fibrosis (genotype or sweat sodium concentration greater than 70 mmol/litre)
- Forced expiratory volume in one second greater than or equal to 25% predicted, on assessment for entry to the study.
Exclusion Criteria
- Evidence of a current respiratory exacerbation (Thornton et al 2004)
- Current severe haemoptysis
- Past history of pneumothorax
- Awaiting lung / heart-lung transplantation
- Pregnancy
- Recent (within 3 months) acquisition of Burkholderia cepacia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Forced expiratory volume in one second (FEV1) 48 weeks
- Secondary Outcome Measures
Name Time Method Quality of life (Short Form-36 and Chronic Respiratory Questionnaire) 48 weeks Exercise capacity (Modified shuttle test) 48 weeks