Cystic FibrosisPhase 4ACTNCT00890370
Should Any One Airway Clearance Technique be Recommended for People With Cystic Fibrosis?
A Phase 4 study testing Airway clearance technique in people with Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust.
Trial 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)). 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?
- Airway clearance technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 1999to Sep 2003
- Phase
- Phase 4
- 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 (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.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Airway clearance technique
- Keywords
- Cystic fibrosis, Airway clearance
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway clearance techniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Active cycle of breathing techniques Receives: Procedure: Airway clearance technique |
| 2 | Other | Autogenic drainage Receives: Procedure: Airway clearance technique |
| 3 | Other | R-C Cornet Receives: Procedure: Airway clearance technique |
| 4 | Other | Flutter Receives: Procedure: Airway clearance technique |
| 5 | Other | PEP Receives: Procedure: Airway clearance technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
Measured: 48 weeks
Secondary outcomes (2)
Quality of life (Short Form-36 and Chronic Respiratory Questionnaire)
Measured: 48 weeks
Exercise capacity (Modified shuttle test)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJul 1999
- Primary completionSep 2003
- Study completionSep 2003
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT00890370
- Sponsor's protocol ID
- 1998CF004B
- Acronym
- ACT
- Status last verified
- Apr 2009
- First submitted
- 28 Apr 2009
- Last updated
- 29 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Five Airway Clearance Techniques in the Treatment of Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00890370
- Acronym / sponsor ID
- ACT / 1998CF004B
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Airway clearance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 1999
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 29 Apr 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Airway clearance techniqueActive cycle of breathing techniques |
| 2 | Other | Procedure: Airway clearance techniqueAutogenic drainage |
| 3 | Other | Procedure: Airway clearance techniqueR-C Cornet |
| 4 | Other | Procedure: Airway clearance techniqueFlutter |
| 5 | Other | Procedure: Airway clearance techniquePEP |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Evidence of a current respiratory exacerbation (Thornton et al 2004)
- Current severe haemoptysis
- Past history of pneumothorax
- Awaiting lung / heart-lung transplantation
- Pregnancy
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 |
|---|---|---|
| Airway clearance technique | Procedure or surgery | 1, 2, 3, 4, 5 |
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: 48 weeks
2 secondary outcomes
Quality of life (Short Form-36 and Chronic Respiratory Questionnaire)
Time frame: 48 weeks
Exercise capacity (Modified shuttle test)
Time frame: 48 weeks
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 29 Apr 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Airway clearance technique in people with Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust.
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 2 inclusion and 6 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 29 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Forced expiratory volume in one second (FEV1) (time frame: 48 weeks). 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 29 Apr 2009.