GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study (GLAD)
Primary Purpose
Asthma, Respiratory
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Physiotherapist
Sponsored by

About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Sham Comparator
Arm Label
1
Arm Description
equal time with health care professional (asthma nurse)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00515840
First Posted
August 13, 2007
Last Updated
November 4, 2015
Sponsor
P Burns
Collaborators
University Hospitals, Leicester
1. Study Identification
Unique Protocol Identification Number
NCT00515840
Brief Title
GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study
Acronym
GLAD
Official Title
GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
P Burns
Collaborators
University Hospitals, Leicester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Respiratory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Sham Comparator
Arm Description
equal time with health care professional (asthma nurse)
Intervention Type
Other
Intervention Name(s)
Physiotherapist
Intervention Description
Physiotherapist administered breathing retraining programme
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Thomas
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study
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