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CompletedNCT00515840GLADUpdated Nov 5, 2015

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

A Phase 3 interventional study of Physiotherapist in Asthma and Respiratory, sponsored by P Burns. Completed. Open to participants aged 17 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-11-05.

Sponsored by P Burns · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
17 Years to 70 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Asthma
  • Respiratory

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03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 182 is above the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

P Burns is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • COPD
  • Unstable or under-treated asthma at enrollment.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
182 participants (actual)

Study arms

  • Sham comparator
    1

    equal time with health care professional (asthma nurse)

    Other: Physiotherapist

Interventions

  • OtherPhysiotherapist

    Physiotherapist administered breathing retraining programme

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00515840
Lead sponsor
P Burns
Collaborators
University Hospitals, Leicester
Responsible party
P Burns (Research Governance Manager, University of Aberdeen) — Sponsor-investigator
First posted
Aug 14, 2007
Start date
Oct 2003
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Nov 5, 2015

Study contacts

Mike Thomas
principal investigator · University of Aberdeen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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