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Trial registered on ANZCTR


Registration number
ACTRN12610000540011
Ethics application status
Approved
Date submitted
11/09/2009
Date registered
6/07/2010
Date last updated
10/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Persistent cough and upper airway dysfunction following H1N1 (swine flu) infection
Scientific title
The prevalence of persistent cough, upper airway dysfunction and voice disorders following H1N1 infection within the Newcastle area community.
Secondary ID [1] 252161 0
nil
Universal Trial Number (UTN)
Trial acronym
SWINECC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
H1N1 (Swine) influenza 243713 0
Persistent Cough 243714 0
Upper Airway Dysfunction 243715 0
Dysphonia 243716 0
Condition category
Condition code
Infection 239980 239980 0 0
Other infectious diseases
Respiratory 239981 239981 0 0
Other respiratory disorders / diseases
Public Health 239982 239982 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To investigate:

1.the prevalence of persistent cough, upper airway dysfunction and dysphonia following H1N1 (swine flu) infection,
2.the role of associated risk factors such as
asthma, rhinitis, gastroesophageal reflux disease, Ace-I use, obstructive sleep apnoea, poor vocal hygiene and other.
3. clinical course and characteristics of post H1N1 persistent cough such as duration, severity, and associated symptoms such as vocal cord dysfunction / Laryngeal Paraesthesia / voice by questionnaire. Cough reflex sensitivity, Extrathoracic airway hyperresponsiveness and Bronchial hyperresponsiveness.
4. mechanisms of increased cough reflex sensitivity and airway hyperresponsiveness,
5. relation to viral persistence.

These observations will take place in a respiratory clinical room of the John Hunter Hospital (JHH) in Newcastle, New South Wales (NSW) and will occur after the potential participant has be identified from the pathology database as having been tested for H1N1 infection and contacted as to their interest to participate in the research study. After consent has been obtained the participant will visit the clinic at (JHH) for a maximum of 2 occassions (first visit will last for around 40 minutes and the second visit of around 50 minutes)* to complete the above observations. * However, these 2 visits may be combined into a single (1) 90 minute visit if appropriate.
Intervention code [1] 241250 0
Not applicable
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240785 0
Cough hypersensitivity.

This will be assessed by a well established breathing test and cough stimulant solution.
Timepoint [1] 240785 0
This will occur at one of the two visits (or a single combined visit for adults when deemed appropriate) that the participant will attend after they have been identified as having previously been tested for H1N1 infection, been contacted about the study and given their consent to participate in the study.
Primary outcome [2] 240786 0
Upper airway hypersensitivity

This will be assessed by a well established breathing test and hypertonic saline solution.
Timepoint [2] 240786 0
This will occur at one visit of the two visits (or a single combined visit for adults when deemed appropriate) that the participant will attend after they have been identified as having previously been tested for H1N1 infection, been contacted about the study and given their consent to participate in the study.
Primary outcome [3] 240787 0
Laryngeal dysfunction by questionnaire
Timepoint [3] 240787 0
This will occur at both of the two visits (or a single combined visit for adults when deemed appropriate) or at the one visit (for children) that the participant will attend after they have been identified as having previously been tested for H1N1 infection, been contacted about the study and given their consent to participate in the study. For adults the second visit will occur approximately 2 weeks after the first visit to the respiratory clinic.
Primary outcome [4] 240788 0
Dysphonia by voice analysis
Timepoint [4] 240788 0
This will occur at one of the two visits (or a single combined visit for adults when deemed appropriate) in the speech pathology clinic that the participant will attend after they have been identified as having previously been tested for H1N1 infection, been contacted about the study and given their consent to participate in the study.
Primary outcome [5] 240789 0
Decreased cough quality of life by Leicester Cough questionnaire.
Timepoint [5] 240789 0
This will occur at both of the two visits (or a single combined visit for adults when deemed appropriate) or at the one visit (for children) that the participant will attend after they have been identified as having previously been tested for H1N1 infection, been contacted about the study and given their consent to participate in the study. For adults the second visit will occur approximately 2 weeks after the first visit to the respiratory clinic.
Secondary outcome [1] 257459 0
Associated risk factors for cough: asthma by asthma control questionnaire (ACQ), Rhinitis by Snot-20 Questionnaire, reflux by Gastroesophageal reflux questionnaire, obstructive sleep apnoea by Berlin questionnaire, and voice handicap by questionnaire.
Timepoint [1] 257459 0
This will occur at second of the two visits (or a single combined visit for adults when deemed appropriate) or at the one visit (for children) that the participant will attend after they have been identified as having previously been tested for H1N1 infection, been contacted about the study and given their consent to participate in the study. For adults the second visit will occur approximately 2 weeks after the first visit to the respiratory clinic.
Secondary outcome [2] 257557 0
Laryngeal paraesthesia by questionnaire.
Timepoint [2] 257557 0
This will occur at the first visit of the two visits (or a single combined visit for adults when deemed appropriate) and at the one visit for children in the speech pathology clinic that the participant will attend after they have been identified as having previously been tested for H1N1 infection, been contacted about the study and given their consent to participate in the study.
Secondary outcome [3] 257558 0
Vocal hygiene by questionnaire and voice testing.
Timepoint [3] 257558 0
This will occur at one of the two visits (or a single combined visit for adults when deemed appropriate) in the speech pathology clinic that the participant will attend after they have been identified as having previously been tested for H1N1 infection, been contacted about the study and given their consent to participate in the study.

Eligibility
Key inclusion criteria
Prior swab for H1N1 infection.
Persistent cough of more than 8 weeks duration.
All persons tested for H1N1 infection from the Hunter Area Pathology database will be invited to take in the questionnaire stage of the study (visit 1, adults and children) then a subset group of 50 subjects in each group (cases/controls) will be taken to physical testing stage (visit 2, adults only).
Informed consent must be obtained prior to commencement of the study.
Minimum age
8 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy/breast feeding
Other active respiratory disease such as Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, etc.
Inability to attend study visit/s.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2009
Actual
4/11/2009
Date of last participant enrolment
Anticipated
Actual
7/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
136
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 243715 0
Government body
Name [1] 243715 0
National Health & Medical Research Council (NH&MRC) Centre of Clinical Research Excellence (CCRE) in Respiratory & Sleep Medicine
Country [1] 243715 0
Australia
Funding source category [2] 243716 0
Hospital
Name [2] 243716 0
John Hunter Hospital Special Trust (SP&T) Funds, respiratory reasearch
Country [2] 243716 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Area Health Service
Address
John Hunter Hospital
Lookout Road, New Lambton Heights, NSW, 2305.
Country
Australia
Secondary sponsor category [1] 237079 0
None
Name [1] 237079 0
Address [1] 237079 0
Country [1] 237079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243843 0
Hunter New England Research Ethics Unit
Ethics committee address [1] 243843 0
Hunter Area Headquarters,
Lookout Road, New Lambton Heights,
NSW 2305.
Ethics committee country [1] 243843 0
Australia
Date submitted for ethics approval [1] 243843 0
Approval date [1] 243843 0
14/09/2009
Ethics approval number [1] 243843 0
09/08/19/5.04

Summary
Brief summary
This new research will investigate the prevalence of persistent cough, breathing difficulties and voice changes following H1N1 (swine flu) infection.
We will also be investigating the role of cough risk factors including asthma, rhinitis (hayfever), reflux, Ace-Inhibitor use (for high blood pressure), obstructive sleep apnoea (a sleep disorder), voice changes, etc. As well as characteristics of persistent cough including length of cough, how severe the cough is, cough sensitivity, associated symptoms, breathing and voice changes.
The current H1N1 influenza pandemic provides an opportunity to address many of the knowledge gaps in post viral cough.

Our hypotheses are that there will be a prevalence of 10% of persistent cough and upper airway dysfunction following H1N1 infection.
That upper airways disorder and heightened cough reflex sensitivity will be
increased following H1N1 infection, and that voice changes will be more prevalent following H1N1 infection.
Trial website
Trial related presentations / publications
Trial related presentations/publications include:
1) Poster Presentation at the Annual TSANZ Meeting, Darwin NT 2011.
2) Ryan NM, Vertigan AE, Ferguson J, Wark P, Gibson PG. Investigation and characterization of persistent cough associated with H1N1 2009 influenza [abstract]. Respirology. 2011;16(Suppl. 1):46.
3) Ryan NM, Vertigan AE, Ferguson J, Wark P, Gibson PG. Clinical and physiological features of postinfectious chronic cough associated with H1N1 infection. Respiratory Medicine. 2011.
Public notes

Contacts
Principal investigator
Name 30174 0
Prof Peter G Gibson
Address 30174 0
Level 2 West Wing, HMRI
Lot 1, Kookaburra Circuit
New Lambton Heights, NSW 2305.
Country 30174 0
Australia
Phone 30174 0
+61240420142
Fax 30174 0
Email 30174 0
Peter.Gibson@hnehealth.nsw.gov.au
Contact person for public queries
Name 13421 0
Dr Nicole M Ryan
Address 13421 0
Clinical Toxicology Research Group, Level 5 New Med Building,
Calvary Mater Newcastle, Edith Street Waratah NSW 2298.
Country 13421 0
Australia
Phone 13421 0
+61249211312
Fax 13421 0
+61240143873
Email 13421 0
Nicole.Ryan@newcastle.edu.au
Contact person for scientific queries
Name 4349 0
Prof Peter G Gibson
Address 4349 0
Level 2 West Wing, HMRI
Lot 1, Kookaburra Circuit
New Lambton Heights, NSW 2305.
Country 4349 0
Australia
Phone 4349 0
+612 40420142
Fax 4349 0
+612 40420046
Email 4349 0
Peter.Gibson@hnehealth.nsw.gov.au

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

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