Clinical Trial: Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary:
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.
Sponsor: NHS Lothian
Current Primary Outcome: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) [ Time Frame: 3 months ]
Original Primary Outcome: quantitative sputum bacteriology [ Time Frame: 3 months ]
Current 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 ]
Original Secondary Outcome: 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 ]
Information By: NHS Lothian
Dates:
Date Received: December 31, 2008
Date Started: October 2007
Date Completion:
Last Updated: March 31, 2011
Last Verified: July 2010
