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Completed

NCT Number: NCT00890370

Should Any One Airway Clearance Technique be Recommended for People With Cystic Fibrosis?

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airway clearance technique

Procedure

Primary outcomes

  1. Forced expiratory volume in one second (FEV1)

    Time frame: 48 weeks

Secondary outcomes

  1. Quality of life (Short Form-36 and Chronic Respiratory Questionnaire)

    Time frame: 48 weeks

  2. Exercise capacity (Modified shuttle test)

    Time frame: 48 weeks

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: ACT

Important dates

Study start
1999
Primary completion
2003
Study completion
2003
First posted
Apr 29, 2009
Registry last updated
Apr 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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