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

This study has been completed.
Sponsor:
Information provided by:
NHS Lothian
ClinicalTrials.gov Identifier:
NCT00816309
First received: December 31, 2008
Last updated: March 31, 2011
Last verified: July 2010
History of Changes

December 31, 2008
March 31, 2011
October 2007
December 2008   (final data collection date for primary outcome measure)
24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
quantitative sputum bacteriology [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00816309 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Bronchiectasis
Device: Acapella Physiotherapy
twice daily- around 20 minutes
  • Experimental: Acapella Physiotherapy
    Physiotherapy with acapella versus no physiotherapy
    Intervention: Device: Acapella Physiotherapy
  • No Intervention: No physiotherapy
    Physiotherapy with acapella versus no physiotherapy
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.
 
Completed
20
March 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate and Severe Bronchiectasis
  • No regular chest physiotherapy

Exclusion Criteria:

  • Moderate or Severe COPD
Both
60 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00816309
AH003
No
Not Provided
Not Provided
Dr Adam Hill, Consultant Respiratory Physician, NHS Lothian, NHS Lothian
NHS Lothian
Not Provided
Principal Investigator: Adam T Hill, MBChB MD NHS Lothian
NHS Lothian
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP