Cystic FibrosisPhase 3NCT00817947
Airway Clearance Using High Frequency Chest Wall Oscillation
A Phase 3 study testing High frequency chest wall oscillation in people with Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous clearance compared with control. These observations led to the development of 'The Vest' which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- High frequency chest wall oscillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of cystic fibrosis
- 16 years of age or over
- forced expiratory volume in one second greater than or equal to 25 percent of predicted
- hospitalised patients in a stable clinical state
Who cannot join
- current severe haemoptysis
- rib fractures
- pregnancy
- inability to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Assessment of the Short-Term Effects of the Airway Clearance Technique of High Frequency Chest Wall Oscillation in People With Cystic Fibrosis
High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous clearance compared with control. These observations led to the development of 'The Vest' which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. The generator rapidly inflates and deflates 'The Vest' which gently compresses and releases the chest wall between 5 and 20 times per second. This generates mini-coughs which are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. In addition 'The Vest' has been shown to reduce the viscosity of mucus and this should further enhance mucous clearance. The technique has, for many years, been widely used in the United States of America as an alternative to the European airway clearance regimens of the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure, but 'The Vest' has only recently been registered for use in Europe. It is important that the airway clearance regimen of 'The Vest' be compared with the alternative airway clearance regimens widely used in Europe.
Hypothesis: In people with cystic fibrosis 'The Vest' will lead to the expectoration of an increased weight of sputum during treatment sessions compared with alternative airway clearance regimens.
- Conditions
- Cystic Fibrosis
- Being tested
- High frequency chest wall oscillation
- Keywords
- Airway clearance, Cystic fibrosis, High frequency chest wall oscillation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency chest wall oscillationDevice
Airway clearance using high frequency chest wall oscillation ('The Vest')
| Study group | Role | What they receive |
|---|---|---|
| Usual airway clearance technique | Active comparator | Airway clearance using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure or oscillating positive expiratory pressure Receives: Device: High frequency chest wall oscillation |
| HFCWO | Other | High frequency chest wall oscillation Receives: Device: High frequency chest wall oscillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight of sputum expectorated
Measured: Twenty-four hours
Secondary outcomes (1)
Forced expiratory volume in one second
Measured: One hour (before and 30 minutes after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJan 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Jennifer A Pryor, PhD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817947
- Sponsor's protocol ID
- 06/Q0404/54
- Status last verified
- Jan 2009
- First submitted
- 6 Jan 2009
- Last updated
- 7 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Short-Term Effects of the Airway Clearance Technique of High Frequency Chest Wall Oscillation in People With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00817947
- Acronym / sponsor ID
- 06/Q0404/54
- Conditions
- Cystic Fibrosis
- Keywords
- Airway clearance, Cystic fibrosis, High frequency chest wall oscillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous clearance compared with control. These observations led to the development of 'The Vest' which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. The generator rapidly inflates and deflates 'The Vest' which gently compresses and releases the chest wall between 5 and 20 times per second. This generates mini-coughs which are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. In addition 'The Vest' has been shown to reduce the viscosity of mucus and this should further enhance mucous clearance. The technique has, for many years, been widely used in the United States of America as an alternative to the European airway clearance regimens of the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure, but 'The Vest' has only recently been registered for use in Europe. It is important that the airway clearance regimen of 'The Vest' be compared with the alternative airway clearance regimens widely used in Europe.
Hypothesis: In people with cystic fibrosis 'The Vest' will lead to the expectoration of an increased weight of sputum during treatment sessions compared with alternative airway clearance regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual airway clearance technique | Active comparator | Device: High frequency chest wall oscillationAirway clearance using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure or oscillating positive expiratory pressure |
| HFCWO | Other | Device: High frequency chest wall oscillationHigh frequency chest wall oscillation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of cystic fibrosis
- 16 years of age or over
- forced expiratory volume in one second greater than or equal to 25 percent of predicted
- hospitalised patients in a stable clinical state
Key exclusion criteria (4 listed)
- current severe haemoptysis
- rib fractures
- pregnancy
- inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High frequency chest wall oscillationAirway clearance using high frequency chest wall oscillation ('The Vest') | Device | HFCWO, Usual airway clearance technique |
Primary outcome
Weight of sputum expectorated
Time frame: Twenty-four hours
1 secondary outcome
Forced expiratory volume in one second
Time frame: One hour (before and 30 minutes after treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Pryor, PhD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High frequency chest wall oscillation in people with Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight of sputum expectorated (time frame: Twenty-four hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2009.