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

Asthma Clinical Trial

— GLAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515840
• Other study ID #: 03/014
• Status: Completed
• Phase: Phase 3
• First received: August 13, 2007
• Last updated: November 4, 2015
• Start date: October 2003
• Est. completion date: December 2007

Study information

• Verified date: November 2015
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Respiratory

Intervention

Other:
• Physiotherapist
Physiotherapist administered breathing retraining programme

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
P Burns	University Hospitals, Leicester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Dec 2006
Secondary	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		Dec 2007