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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University of Aberdeen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT00515840
First received: August 13, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Asthma
Dysfunctional Breathing
Other: Physiotherapist
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

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 [ Time Frame: Dec 2006 ]

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 [ Time Frame: Dec 2007 ]

Enrollment: 182
Study Start Date: October 2003
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
Sham Comparator: 1
equal time with health care professional (asthma nurse)
Other: Physiotherapist
Physiotherapist administered breathing retraining programme

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
  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515840

Sponsors and Collaborators
University of Aberdeen
University Hospitals, Leicester
Investigators
Principal Investigator: Mike Thomas University of Aberdeen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00515840     History of Changes
Other Study ID Numbers: 03/014
Study First Received: August 13, 2007
Last Updated: August 13, 2007
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 16, 2014