GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study (GLAD)

November 4, 2015 updated by: P Burns

Breathing retraining supervised by a physiotherapist will result in improvements in the quality of life and asthma control of patients treated for asthma in the community with symptoms suggestive of dysfunctional breathing.

To investigate the effects of breathing retraining on clinical and physiological parameters of asthma control, to identify the characteristics of patients who benefit, to perform a health economic evaluation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives:

  • To assess the effect of breathing retraining on asthma-related health status, asthma control and objective indices of asthma severity (bronchial hyper-reactivity (BHR), sputum eosinophilia and nitric oxide production) in patients with symptomatic asthma.
  • To compare the relationship between symptoms of dysfunctional breathing (Nijmegen Questionnaire screening score), changes in asthma-related health status and other parameters resulting from breathing retraining
  • To explore the relationship between dysfunctional breathing, baseline asthma symptoms, treatment and asthma-related quality of life.
  • To estimate the cost effectiveness of the breathing retraining intervention

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 3

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

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asthma diagnosis in medical records
  • Age 17-70 yrs.
  • One or more prescription for asthma medication in previous 12 months
  • Impaired asthma related quality of life (AQLQ score <5.5)

Exclusion Criteria:

  • COPD
  • Unstable or under-treated asthma at enrollment.

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 1
equal time with health care professional (asthma nurse)
Other: Physiotherapist
Physiotherapist administered breathing retraining programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in AQLQ scores between intervention and control groups in subjects with positive NQ screening scores 1 month post intervention Change in AQLQ scores between intervention groups of subjects with positive and negative NQ screening scores
Time Frame: Dec 2006
Dec 2006

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in bronchial hyperresponsiveness(PC 20), sputum eosinophil counts and exhaled NO between intervention and control groups in subjects with positive and negative NQ screening scores Change in ACQ Score between the intervention and the control gr
Time Frame: Dec 2007
Dec 2007

Collaborators and Investigators

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

Sponsor

P Burns

Collaborators

University Hospitals, Leicester

Investigators

  • Principal Investigator: Mike Thomas, University of Aberdeen

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, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 13, 2007

First Posted (Estimate)

August 14, 2007

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/014

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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