Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
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ClinicalTrials.gov Identifier: NCT00816309 |
Recruitment Status
:
Completed
First Posted
: January 1, 2009
Last Update Posted
: April 1, 2011
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Tracking Information | ||||
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First Submitted Date ICMJE | December 31, 2008 | |||
First Posted Date ICMJE | January 1, 2009 | |||
Last Update Posted Date | April 1, 2011 | |||
Study Start Date ICMJE | October 2007 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) [ Time Frame: 3 months ] | |||
Original Primary Outcome Measures ICMJE |
quantitative sputum bacteriology [ Time Frame: 3 months ] | |||
Change History | Complete list of historical versions of study NCT00816309 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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 ] | |||
Original Secondary Outcome Measures ICMJE |
spirometry (FEV1, FVC, FEF 25-75), incremental shuttle test, 24hour sputum volume, sputum colour, Leicester cough questionnaire,St George's Respiratory Questionnaire and Nottingham Health Profile NHP-2. [ Time Frame: 3 months ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis? | |||
Official Title ICMJE | Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis? | |||
Brief 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. 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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Bronchiectasis | |||
Intervention ICMJE | Device: Acapella Physiotherapy
twice daily- around 20 minutes |
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Study Arms |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
20 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | March 2009 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 60 Years to 85 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00816309 | |||
Other Study ID Numbers ICMJE | AH003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Dr Adam Hill, Consultant Respiratory Physician, NHS Lothian, NHS Lothian | |||
Study Sponsor ICMJE | NHS Lothian | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | NHS Lothian | |||
Verification Date | July 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |