NCT00697177

Brief Summary

Gastric reflux into the oesophagus may further lung damage in respiratory disease. The proportion of adults with chronic lung disease and gastric reflux is unknown. Adults with this disease regularly complete physiotherapy but the contribution of physiotherapy to reflux is unknown. This study will measure gastric reflux in adults with chronic lung disease, using 24 hour acid monitoring. It is anticipated that approximately 50% of adults with chronic lung disease will have gastric reflux. After monitoring, the number of gastric reflux episodes will be calculated. The results will identify the extent of the gastric reflux problem in these patients and will enable appropriate medical treatment and modifications to physiotherapy, which may improve lung function and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 15, 2013

Status Verified

September 1, 2005

Enrollment Period

3.9 years

First QC Date

September 9, 2005

Last Update Submit

February 12, 2013

Conditions

Keywords

Gastro-oesophageal reflux24 hour oesophageal pH monitoringPhysiotherapy Airway clearance techniquesExercise

Outcome Measures

Primary Outcomes (1)

  • Prevalence of GOR

    12 months

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with COPD and bronchiectasis

You may qualify if:

  • Diagnosis of Chronic obstructive pulmonary disease according to GOLD classification
  • Diagnosis of Bronchiectasis
  • Medically stable, without hospital admission in month prior to study

You may not qualify if:

  • diagnosis of asthma, cystic fibrosis, interstitial lung disease
  • known hiatus hernia, oesophageal varices, obstructive sleep apnoea
  • medically unstable for exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchiectasisGastroesophageal RefluxMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesBehavior

Study Officials

  • Annemarie L Lee, BPhys, MPhys

    University of Melbourne

    PRINCIPAL INVESTIGATOR
  • Brenda M Button, DPhysio, PhD

    The Alfred

    PRINCIPAL INVESTIGATOR
  • John W Wilson, MBBS, PhD

    The Alfred

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

June 13, 2008

Study Start

July 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 15, 2013

Record last verified: 2005-09

Locations