search
Back to results

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
P Burns
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 13, 2007
    Last Updated
    November 4, 2015
    Sponsor
    P Burns
    Collaborators
    University Hospitals, Leicester
    search

    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

    We'll reach out to this number within 24 hrs