Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000449033
Ethics application status
Approved
Date submitted
28/05/2010
Date registered
2/06/2010
Date last updated
2/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The differential effect of gastroesophageal reflux disease on laryngo-hypopharyngeal mechanosensitivity and chemosensitivity.
Scientific title
The differential effect of gastroesophageal reflux disease on laryngo-hypopharyngeal mechanosensitivity and chemosensitivity.
Secondary ID [1] 251894 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux 257485 0
Laryngeal sensitivity 257486 0
Condition category
Condition code
Respiratory 257636 257636 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 257637 257637 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Effect of mechanical stimulation on laryngeal sensitivity.Effect of Hydrochloric Acid (HCl) on Laryngeal sensitivity

Patients and Controls will undergo nasoendoscopy and have mechanosensitivity assessed by determing the threshold of air pressure required (in mmHg) to elicit the laryngeal adductor reflex. Air pressure will be delivered via a specific channel in the nasoendoscope, and is generated by the Pentax AP4000 air pressure generator.

Laryngeal sensitivity will be determined by visualisng a swallow or vocal cord response to the instillation of normal saline and 0.1N HCl (hydrochloric acid).

This procedure will be performed on 2 occasions (1 week apart) in patients and control subjects, with subjects being their own controls. Saline and HCl will be administered on separate occasions.
Intervention code [1] 256583 0
Not applicable
Comparator / control treatment
There are 2 sets of controls used in this study.

The first are subjects without gastro-oesophgeal reflux disease(GORD). These subjects will undergo 2 nasoendoscopy procedures, identical to patients with GORD

In addition historical controls (1999-2005) with retrospective patients data will be used for some parameters including the normal range of thresholds for the laryngeal adductor response.
Control group
Active

Outcomes
Primary outcome [1] 258547 0
Laryngeal mechanosensitivity as measured by laryngeal adductor reflex (LAR)
Timepoint [1] 258547 0
% change in pressure required to elicit LAR (min 0.5mmHg)

This is measured immediately after the adminstration of air pressure
Primary outcome [2] 258569 0
Laryngeal chemo-sensitivity as measure by volume of acid infused to elicit response
Timepoint [2] 258569 0
% change in volume of acid infused to elicit laryngeal response (min 0.1ml)

This is measured immediately after adminsitration of acid
Secondary outcome [1] 264392 0
Correlation between changes in mechano and chemo-sensitivity responses in controls and patients with Gastro-oesophageal Reflux Disease (GORD).
Timepoint [1] 264392 0
Linear correlation bewteen mechano and chemo responses in patients and controls. This is performed immediately after stimulation with both air pressure and acid.

Eligibility
Key inclusion criteria
Presence of gastro-oesophageal reflux disease (GORD)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant preexisting pulmonary or laryngeal pathology
Prior Cerebrovascular accident

Eligible Participants will be deemed healthy apart from the presence of Gastro-oesophageal reflux disease.

Controls will all be deemed healthy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257076 0
Hospital
Name [1] 257076 0
Concord Hospital
Country [1] 257076 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 256335 0
None
Name [1] 256335 0
Address [1] 256335 0
Country [1] 256335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259100 0
Concord Hospital Ethics Committee
Ethics committee address [1] 259100 0
Hospital Rd.
Concord NSW 2139
Ethics committee country [1] 259100 0
Australia
Date submitted for ethics approval [1] 259100 0
Approval date [1] 259100 0
Ethics approval number [1] 259100 0
CH62/6/1048

Summary
Brief summary
We have observed that patients with gastro-oesophageal reflux disease (GORD) have an increased incidence of upper and lower respiratory infections. In addition GORD is strongly associated with bronchial asthma. This study seeks to identify whether patients with GORD have impaired mechano or chemo laryngeal sensitivity which may reduced airway protective mechanisms and lead to an increased risk of pulmonary aspiration of gastric acid.

This study therefore aims to determine the mechano and chemo senitivity of laryngeal protective mechanisms in patients with GORD and healthy controls
Trial website
Trial related presentations / publications
Phua S.Y., McGarvey L.P., Ngu M.C.. and Ing A.J. Patients with gastroesophageal reflux and cough have impaired laryngopharyngeal mechanosensitivity. Thorax 2005; 60: 488-91.

Phua S.Y., McGarvey L.P., Ngu MC. and Ing A.J. The differential effect of gastroesophageal reflux disease on laryngo-hypopharyngeal mechanosensitivity and chemosensitivity Chest 2010: In Press
Public notes

Contacts
Principal investigator
Name 31239 0
Address 31239 0
Country 31239 0
Phone 31239 0
Fax 31239 0
Email 31239 0
Contact person for public queries
Name 14486 0
Alvin Ing
Address 14486 0
Level 7W
Concord Hospital
Hospital RD
Concord NSW 2139
Country 14486 0
Australia
Phone 14486 0
61 2 97676712
Fax 14486 0
Email 14486 0
[email protected]
Contact person for scientific queries
Name 5414 0
Alvin Ing
Address 5414 0
Level 7W
Concord Hospital
Hospital RD
Concord NSW 2139
Country 5414 0
Australia
Phone 5414 0
61 2 97676712
Fax 5414 0
Email 5414 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe differential effect of gastroesophageal reflux disease on mechanostimulation and chemostimulation of the laryngopharynx.2010https://dx.doi.org/10.1378/chest.09-2387
N.B. These documents automatically identified may not have been verified by the study sponsor.