Dysfunctional Breathing in Difficult Asthma.

This study has been withdrawn prior to enrollment.
(Life shirt technology no longer available)
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00716677
First received: July 15, 2008
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

We plan to use the Life Shirt to record tidal volume, respiratory rate and breathing pattern over a 6 hour period in patients admitted with difficult asthma. The Life Shirt will also be used to collect the same data over the same time period in a group of healthy controls. This data will then be correlated with the assessment of the supervising consultant as to whether the patient has any element of dysfunctional breathing contributing to their symptoms. It is hoped that the data obtained may in future be used to offer treatment to those patients with dysfunctional breathing.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Ambulatory Respiratory Inductance Plethysmography (RIP). Can it be Used to Help Identify Dysfunctional Breathing in Difficult Asthma?

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Prevalence of dysfunctional breathing patterns in patients with difficult to control asthma compared with healthy volunteers [ Time Frame: 12/2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2. Prevalence of dysfunctional breathing patterns in patients with confirmed severe refractory asthma as defined by ATS criteria. [ Time Frame: 12/2010 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Detailed Description:

Hypothesis

Dysfunctional breathing patterns are more prevalent in patients with a diagnosis of difficult to treat asthma than healthy volunteers.

Design

This will be an open, prospective study, recruiting sequential patients admitted electively to undergo the difficult asthma protocol (DAP). These patients are generally admitted during a period of stability, but still have significant symptoms despite asthma therapy. Healthy volunteers will be recruited from hospital staff and their family and friends.

We will recruit patients over a 12 to 18 month period and hope to enrol 60 patients. On the final day of their 4 day admission, patients will be asked to wear the life vest from 0800hrs. During the morning they will undergo a 6 minute walk to test to assess their responses during exercise. They will also be reviewed by the supervising consultant to discuss the results of their investigations. While wearing the shirt, the patient will be asked to keep a diary of their activities and symptoms. The Life Shirt can be removed by the patient at the time of discharge.

20 Healthy volunteers will be recruited from the hospital staff. They will be asked to wear the life vest while undertaking their normal daily activities. They will also undertake a 6 minute walk test.

Tidal volume, minute volume and respiratory rate will be recorded at rest and during exertion, aided by the patient diary. Breathing pattern and features of dysfunctional breathing, such as frequent sighs, will also be noted. This will subsequently be correlated with the assessment of the supervising consultant with regard to the presence of dysfunctional breathing.

Data will also be analysed with regard to whether there are any differences between healthy volunteers, patients felt to have asthma, and those felt not to have asthma by their admitting consultant.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with physician diagnosis of difficult asthma

Criteria

Inclusion Criteria:

  • Physician diagnosis of difficult asthma

Exclusion Criteria:

  • Current breastfeeding
  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: NCT00716677

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Andrew N Menzies-Gow, MB BS PhD Royal Brompton Hospital
  More Information

No publications provided

Responsible Party: Dr Andrew Menzies-Gow, Royal Brompton Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00716677     History of Changes
Other Study ID Numbers: 08/H0708/35
Study First Received: July 15, 2008
Last Updated: December 31, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
difficult asthma
respiratory inductance plethysmography

Additional relevant MeSH terms:
Respiratory Aspiration
Asthma
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014