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
  Purpose

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.


Condition Intervention Phase
Bronchiectasis
Device: Acapella Physiotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?

Resource links provided by NLM:


Further study details as provided by NHS Lothian:

Primary Outcome Measures:
  • 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acapella Physiotherapy
Physiotherapy with acapella versus no physiotherapy
Device: Acapella Physiotherapy
twice daily- around 20 minutes
No Intervention: No physiotherapy
Physiotherapy with acapella versus no physiotherapy

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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate and Severe Bronchiectasis
  • No regular chest physiotherapy

Exclusion Criteria:

  • Moderate or Severe COPD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816309

Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Sponsors and Collaborators
NHS Lothian
Investigators
Principal Investigator: Adam T Hill, MBChB MD NHS Lothian
  More Information

No publications provided by NHS Lothian

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Adam Hill, Consultant Respiratory Physician, NHS Lothian, NHS Lothian
ClinicalTrials.gov Identifier: NCT00816309     History of Changes
Other Study ID Numbers: AH003
Study First Received: December 31, 2008
Last Updated: March 31, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by NHS Lothian:
physiotherapy
bronchiectasis

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014