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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Airway clearance technique
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic fibrosis, Airway clearance

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Other

    Other

    Other

    Other

    Other

    Arm Label

    1

    2

    3

    4

    5

    Arm Description

    Active cycle of breathing techniques

    Autogenic drainage

    R-C Cornet

    Flutter

    PEP

    Outcomes

    Primary Outcome Measures

    Forced expiratory volume in one second (FEV1)

    Secondary Outcome Measures

    Quality of life (Short Form-36 and Chronic Respiratory Questionnaire)
    Exercise capacity (Modified shuttle test)

    Full Information

    First Posted
    April 28, 2009
    Last Updated
    April 28, 2009
    Sponsor
    Royal Brompton & Harefield NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00890370
    Brief Title
    Should Any One Airway Clearance Technique be Recommended for People With Cystic Fibrosis?
    Acronym
    ACT
    Official Title
    A Comparison of Five Airway Clearance Techniques in the Treatment of Adults With Cystic Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1999 (undefined)
    Primary Completion Date
    September 2003 (Actual)
    Study Completion Date
    September 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Royal Brompton & Harefield NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis
    Keywords
    Cystic fibrosis, Airway clearance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Arm Description
    Active cycle of breathing techniques
    Arm Title
    2
    Arm Type
    Other
    Arm Description
    Autogenic drainage
    Arm Title
    3
    Arm Type
    Other
    Arm Description
    R-C Cornet
    Arm Title
    4
    Arm Type
    Other
    Arm Description
    Flutter
    Arm Title
    5
    Arm Type
    Other
    Arm Description
    PEP
    Intervention Type
    Procedure
    Intervention Name(s)
    Airway clearance technique
    Primary Outcome Measure Information:
    Title
    Forced expiratory volume in one second (FEV1)
    Time Frame
    48 weeks
    Secondary Outcome Measure Information:
    Title
    Quality of life (Short Form-36 and Chronic Respiratory Questionnaire)
    Time Frame
    48 weeks
    Title
    Exercise capacity (Modified shuttle test)
    Time Frame
    48 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer A Pryor, PhD
    Organizational Affiliation
    Royal Brompton & Harefield NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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