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

NCT ID: NCT00515840

Last Updated: 2015-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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

Conditions

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Asthma Respiratory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

equal time with health care professional (asthma nurse)

Group Type SHAM_COMPARATOR

Physiotherapist

Intervention Type OTHER

Physiotherapist administered breathing retraining programme

Interventions

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Physiotherapist

Physiotherapist administered breathing retraining programme

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals, Leicester

OTHER

Sponsor Role collaborator

P Burns

OTHER

Sponsor Role lead

Responsible Party

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P Burns

Research Governance Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mike Thomas

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Other Identifiers

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03/014

Identifier Type: -

Identifier Source: org_study_id

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