Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?

Tracking Information
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; (submitted: February 9, 2009)	24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) [ Time Frame: 3 months ]
Original Primary Outcome Measures ICMJE; (submitted: December 31, 2008)	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; (submitted: February 9, 2009)	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; (submitted: December 31, 2008)	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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Bronchiectasis
Intervention ICMJE	Device: Acapella Physiotherapy; twice daily- around 20 minutes
Study Arms	Experimental: Acapella Physiotherapy Physiotherapy with acapella versus no physiotherapy Intervention: Device: Acapella Physiotherapy; No Intervention: No physiotherapy Physiotherapy with acapella versus no physiotherapy
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 31, 2008)	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: Moderate and Severe Bronchiectasis; No regular chest physiotherapy Exclusion Criteria: Moderate or Severe COPD
Sex/Gender	Sexes Eligible for Study: All
Ages	60 Years to 85 Years (Adult, Older Adult)
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	Principal Investigator: Adam T Hill, MBChB MD NHS Lothian
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