Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000300673
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
5/09/2005
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mechanisms and treatment of chronic cough
Scientific title
Mechanisms and treatment of chronic cough
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic chronic cough 388 0
Condition category
Condition code
Respiratory 460 460 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cough provocation using 3 different doses of nebulized capsaicin; cough provocation using eucapnic voluntary hyperpnea. One visit for each intervention will be required for the recruited patients.
Intervention code [1] 290 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 521 0
In the first visit of the study, the history of chronic cough will be elucidated and all investigations already performed by their medical doctors will be recorded. Once all the investigations for common causes of cough were performed and a cause for chronic cough is still obscure, we will book a second visit to perform provocation with capsaicin, to evaluate the possible primary hypersensitivity of the airways.
Timepoint [1] 521 0
Secondary outcome [1] 1116 0
A third visit will be booked to evaluate the response of the airways and cough to dry air by eucapnic voluntary hyperpnea. This provocation has the purpose of evaluating the association between chronic cough and dryness of the airways.
Timepoint [1] 1116 0

Eligibility
Key inclusion criteria
Diagnosed with chronic cough that has been present for over 8 weeks, subjects with chronic cough will fall into two categories: cause of chronic cough is well-defined ie mild asthmatics, gastro-oesophageal reflux sufferers, rhinosinusitis sufferers, etc.; cause of chronic cough is obscure, and previous investigations have failed to identify a cause.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Upper or lower airway infection in the past four weeks;Pregnancy: female participants of child bearing potential will be tested for pregnancy, by urine pregnancy test, before the capsaicin provocation, and if found to be pregnant will be excluded from the study; Smokers;Uncontrolled major diseases, including psychiatric disorders, heart conditions, high blood pressure or others deemed of significance by the investigator;People with any reported allergic reaction to pepper or ethanol.

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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Estimate - details not known
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 511 0
Hospital
Name [1] 511 0
Westmead Hospital
Country [1] 511 0
Australia
Funding source category [2] 512 0
Other
Name [2] 512 0
Woolcock Institute of Medical Research
Country [2] 512 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 419 0
Hospital
Name [1] 419 0
Westmead Hospital
Address [1] 419 0
Country [1] 419 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302243 0
Unknown
Ethics committee address [1] 302243 0
Ethics committee country [1] 302243 0
Australia
Date submitted for ethics approval [1] 302243 0
01/09/2005
Approval date [1] 302243 0
01/09/2005
Ethics approval number [1] 302243 0
Unknown

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

Contacts
Principal investigator
Name 35770 0
Address 35770 0
Country 35770 0
Phone 35770 0
Fax 35770 0
Email 35770 0
Contact person for public queries
Name 9479 0
Ms Wendy Taylor
Address 9479 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9479 0
Australia
Phone 9479 0
+61 2 95156578
Fax 9479 0
+61 2 95505865
Email 9479 0
wtaylor@woolcock.org.au
Contact person for scientific queries
Name 407 0
Dr Virginia Noronha
Address 407 0
Allergen Group
University of Sydney
Room 461 Blackburn Building D06
Camperdown NSW 2006
Country 407 0
Australia
Phone 407 0
+61 2 93517417
Fax 407 0
+61 2 93517451
Email 407 0
vnoronha@mail.med.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.