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Clinical Trials/NCT00890370
NCT00890370
Completed
Phase 4

A Comparison of Five Airway Clearance Techniques in the Treatment of Adults With Cystic Fibrosis

Royal Brompton & Harefield NHS Foundation Trust0 sites75 target enrollmentJuly 1999
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.

Registry
clinicaltrials.gov
Start Date
July 1999
End Date
September 2003
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

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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