Should Any One Airway Clearance Technique be Recommended for People With Cystic Fibrosis? (ACT)
April 28, 2009 updated by: Royal Brompton & Harefield NHS Foundation Trust
A Comparison of Five Airway Clearance Techniques in the Treatment of Adults 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: 1
Active cycle of breathing techniques
|
|
|
OTHER: 2
Autogenic drainage
|
|
|
OTHER: 3
R-C Cornet
|
|
|
OTHER: 4
Flutter
|
|
|
OTHER: 5
PEP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Forced expiratory volume in one second (FEV1)
Time Frame: 48 weeks
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life (Short Form-36 and Chronic Respiratory Questionnaire)
Time Frame: 48 weeks
|
48 weeks
|
|
Exercise capacity (Modified shuttle test)
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1999
Primary Completion (ACTUAL)
September 1, 2003
Study Completion (ACTUAL)
September 1, 2003
Study Registration Dates
First Submitted
April 28, 2009
First Submitted That Met QC Criteria
April 28, 2009
First Posted (ESTIMATE)
April 29, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 29, 2009
Last Update Submitted That Met QC Criteria
April 28, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1998CF004B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.