BronchiectasisPhase 4NCT00816309
Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
A Phase 4 study testing Acapella Physiotherapy in people with Bronchiectasis, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Acapella Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2007to Mar 2009
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate and Severe Bronchiectasis
- No regular chest physiotherapy
Who cannot join
- Moderate or Severe COPD
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA
About this study
Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.
Read the detailed description
Study being carried out in the Department of Respiratory Medicine, Royal Infirmary of Edinburgh.
The study is entitled "Is regular chest physiotherapy an effective treatment in severe, non cystic fibrosis bronchiectasis?" This is a small randomised controlled pilot crossover study assessing the efficacy of regular chest physiotherapy using an Acapella mouthpiece in severe non cystic fibrosis bronchiectasis. 10 patients will be randomised to receive full instruction in use of the Acapella device (twice daily therapy) and ten patients will continue with their standard treatment regimen. The study will be conducted over seven months.
At the beginning we will randomly allocate them to receive either the current standard treatment regimen for bronchiectasis or to receive instruction in the use of the Acapella physiotherapy device for the first 3 months.
After these 3 months all will receive the current standard treatment regimen for 1 month.
Following this, those that received current standard treatment will receive Acapella physiotherapy device for 3 months and those that received Acapella physiotherapy device will stop this and receive current standard treatment for 3 months.
All participants will be reviewed on 6 occasions (start of study and then at months 1, 2, 3, 4 and 6). At each review, sputum samples will be collected, routine bloods, spirometry and exercise testing performed and health related quality of life questionnaires be completed.
At the end of the study should patients have felt benefit with the physiotherapy with the Acapella device, they should continue using it regularly on a twice-daily basis.
- Conditions
- Bronchiectasis
- Being tested
- Acapella Physiotherapy
- Keywords
- physiotherapy, bronchiectasis
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella PhysiotherapyDevice
twice daily- around 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Acapella Physiotherapy | Experimental | Physiotherapy with acapella versus no physiotherapy Receives: Device: Acapella Physiotherapy |
| No physiotherapy | No intervention | Physiotherapy with acapella versus no physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire)
Measured: 3 months
Secondary outcomes (1)
spirometry (FEV1, FVC, FEF 25-75), incremental shuttle test, St George's Respiratory Questionnaire and Nottingham Health Profile NHP-2, quantitative bacteriology.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Investigators
- Adam T Hill, MBChB MD, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816309
- Sponsor's protocol ID
- AH003
- Status last verified
- Jul 2010
- First submitted
- 31 Dec 2008
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Nov;34(5):1086-92. doi: 10.1183/09031936.00055509. Epub 2009 Jun 18.
PubMed 19541717
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
- ClinicalTrials.gov ID
- NCT00816309
- Acronym / sponsor ID
- AH003
- Conditions
- Bronchiectasis
- Keywords
- physiotherapy, bronchiectasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 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.
Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.
Detailed description
Study being carried out in the Department of Respiratory Medicine, Royal Infirmary of Edinburgh.
The study is entitled "Is regular chest physiotherapy an effective treatment in severe, non cystic fibrosis bronchiectasis?" This is a small randomised controlled pilot crossover study assessing the efficacy of regular chest physiotherapy using an Acapella mouthpiece in severe non cystic fibrosis bronchiectasis. 10 patients will be randomised to receive full instruction in use of the Acapella device (twice daily therapy) and ten patients will continue with their standard treatment regimen. The study will be conducted over seven months.
At the beginning we will randomly allocate them to receive either the current standard treatment regimen for bronchiectasis or to receive instruction in the use of the Acapella physiotherapy device for the first 3 months.
After these 3 months all will receive the current standard treatment regimen for 1 month.
Following this, those that received current standard treatment will receive Acapella physiotherapy device for 3 months and those that received Acapella physiotherapy device will stop this and receive current standard treatment for 3 months.
All participants will be reviewed on 6 occasions (start of study and then at months 1, 2, 3, 4 and 6). At each review, sputum samples will be collected, routine bloods, spirometry and exercise testing performed and health related quality of life questionnaires be completed.
At the end of the study should patients have felt benefit with the physiotherapy with the Acapella device, they should continue using it regularly on a twice-daily basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acapella Physiotherapy | Experimental | Device: Acapella PhysiotherapyPhysiotherapy with acapella versus no physiotherapy |
| No physiotherapy | No intervention | –Physiotherapy with acapella versus no physiotherapy |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate and Severe Bronchiectasis
- No regular chest physiotherapy
Key exclusion criteria (1 listed)
- Moderate or Severe COPD
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 |
|---|---|---|
| Acapella Physiotherapytwice daily- around 20 minutes | Device | Acapella Physiotherapy |
Primary outcome
24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire)
Time frame: 3 months
1 secondary outcome
spirometry (FEV1, FVC, FEF 25-75), incremental shuttle test, St George's Respiratory Questionnaire and Nottingham Health Profile NHP-2, quantitative bacteriology.
Time frame: 3 months
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 1 Apr 2011.
- Derived from this study: PubMed 19541717Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Nov;34(5):1086-92. doi: 10.1183/09031936.00055509. Epub 2009 Jun 18.
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Bronchiectasis
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.
Adam T Hill, MBChB MD principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acapella Physiotherapy in people with Bronchiectasis, run by NHS Lothian 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 2 inclusion and 1 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 1 Apr 2011. 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 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?
24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00816309, which also lists 1 linked publication.
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 1 Apr 2011.