NCT00890370
Completed
Phase 4
A Comparison of Five Airway Clearance Techniques in the Treatment of Adults With Cystic Fibrosis
ConditionsCystic Fibrosis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Enrollment
- 75
- Primary Endpoint
- Forced expiratory volume in one second (FEV1)
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Forced expiratory volume in one second (FEV1)
Time Frame: 48 weeks
Secondary Outcomes
- Quality of life (Short Form-36 and Chronic Respiratory Questionnaire)(48 weeks)
- Exercise capacity (Modified shuttle test)(48 weeks)
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