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

March 31, 2011 updated by: NHS Lothian
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate and Severe Bronchiectasis
  • No regular chest physiotherapy

Exclusion Criteria:

  • Moderate or Severe COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Lothian

Investigators

  • Principal Investigator: Adam T Hill, MBChB MD, NHS Lothian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

December 31, 2008

First Submitted That Met QC Criteria

December 31, 2008

First Posted (Estimate)

January 1, 2009

Study Record Updates

Last Update Posted (Estimate)

April 1, 2011

Last Update Submitted That Met QC Criteria

March 31, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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