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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00890370
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Procedure: Airway clearance technique Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Five Airway Clearance Techniques in the Treatment of Adults With Cystic Fibrosis
Study Start Date : July 1999
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
1
Active cycle of breathing techniques
 Procedure: Airway clearance technique
2
Autogenic drainage
 Procedure: Airway clearance technique
3
R-C Cornet
 Procedure: Airway clearance technique
4
Flutter
 Procedure: Airway clearance technique
5
PEP
 Procedure: Airway clearance technique


Outcome Measures
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Primary Outcome Measures :
  1. Forced expiratory volume in one second (FEV1) [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890370


Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Jennifer A Pryor, PhD Royal Brompton & Harefield NHS Foundation Trust
More Information
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Responsible Party: Dr Jennifer A Pryor, Royal Brompton & Harefield NHS Trust
ClinicalTrials.gov Identifier: NCT00890370    
Other Study ID Numbers: 1998CF004B
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Cystic fibrosis
Airway clearance
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases