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Trial registered on ANZCTR


Trial ID
ACTRN12605000306617
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
6/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cough and reflux
Scientific title
Using a novel pH-cough meter to objectively study acid reflux and cough in children
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cough 394 0
Condition category
Condition code
Respiratory 466 466 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of pH-cough meter and proton pump inhibitor. 8 weeks for PPI.
Intervention code [1] 302 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 527 0
Cough
Timepoint [1] 527 0
Measured at baseline and end of 8 weeks.
Secondary outcome [1] 1132 0
Time relationship between cough and pH as recorded on pH-cough meter
Timepoint [1] 1132 0
Measured at baseline.
Secondary outcome [2] 1133 0
Cough sensitivity measures
Timepoint [2] 1133 0
Measured at baseline.
Secondary outcome [3] 1134 0
Bronchoalveolar markers
Timepoint [3] 1134 0
Measured at baseline.

Eligibility
Key inclusion criteria
Children referred togastroenterologists at the Royal Children'sHospital with suspected GORD and undergoing pHmetry.
Minimum age
6 Months
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications for use of lansoprazole, clinical history of primary aspiration (neuromuscular problems, suppurative lung disease, children receiving additional concomitant new therapy for any pulmonary disorder.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 522 0
Charities/Societies/Foundations
Name [1] 522 0
Royal Children's Hospital Foundation
Address [1] 522 0
Country [1] 522 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 425 0
Individual
Name [1] 425 0
Anne Chang
Address [1] 425 0
Country [1] 425 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35235 0
Address 35235 0
Country 35235 0
Phone 35235 0
Fax 35235 0
Email 35235 0
Contact person for public queries
Name 9491 0
Anne B Chang
Address 9491 0
Department of Respiratory Medicine
Royal Children's Hospital
Herston QLD 4029
Country 9491 0
Australia
Phone 9491 0
+61 7 36369149
Fax 9491 0
+61 7 36361958
Email 9491 0
annechang@ausdoctors.net
Contact person for scientific queries
Name 419 0
Ria Halstead
Address 419 0
Department of Respiratory Medicine
Royal Children's Hospital
Herston QLD 4029
Country 419 0
Australia
Phone 419 0
+61 7 36361956
Fax 419 0
+61 7 36361958
Email 419 0
ria_halstead@health.qld.gov.au