Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000284369
Ethics application status
Approved
Date submitted
16/05/2008
Date registered
4/06/2008
Date last updated
16/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing cough reflex sensitivity in chronic cough patients before, during and after speech pathology intervention.
Scientific title
Comparing cough reflex sensitivity in chronic cough patients before, during and after speech pathology intervention.
Secondary ID [1] 284455 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SPECC2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic cough 3155 0
Condition category
Condition code
Respiratory 3312 3312 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cough specific speech therapy 1hour/session for a duration of 4 sessions.
Intervention code [1] 2888 0
Treatment: Other
Comparator / control treatment
measure of cough hypersensitivity and cough frequency before, during and after each speech treatment session.
Control group
Dose comparison

Outcomes
Primary outcome [1] 4204 0
Decrease in Cough Reflex Sensitivity (C5) by 1.2uMol.
Timepoint [1] 4204 0
Pre-speech treatment session 1, then after each subsequent speech session and finally post-speech treatments (4 sessions completed)
Secondary outcome [1] 7103 0
Decrease in Cough Frequency
Timepoint [1] 7103 0
Pre-speech treatment session 1, then after each subsequent speech session and finally post-speech treatments (4 sessions completed)
Secondary outcome [2] 7104 0
return to normal thoraco-abdominal breathing as determined by chart readout from inductance plethsmyograph with powerlab analogue to digital converter.
Timepoint [2] 7104 0
Pre-speech treatment session 1, then after each subsequent speech session and finally post-speech treatments (4 sessions completed)
Secondary outcome [3] 7105 0
Increase in Leicester Cough Questionnaire>2.56.
Timepoint [3] 7105 0
before first speech session and post speech sessions (4 in total).

Eligibility
Key inclusion criteria
A persistent cough of eight or more weeks duration
Aged between 18 and 80 years
A non-smoker
No other active lung or heart problem
Have been well over the last four weeks
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current Smoker or smoking history > 10 pack Years, Pregnancy/breast feeding, Other respiratory disease such as bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), inability to attend study/speech sessions, respiratory tract infection during month prior to treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with chronic cough are referred to the outpatient speech pathology clinic where they are informed about the research study and offered participation. The patient can select to enter the trial or just continue with usual standard treatment of cough by a speech pathologist.
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2008
Actual
4/08/2009
Date of last participant enrolment
Anticipated
Actual
27/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2339 0
John Hunter Hospital Royal Newcastle Centre - New Lambton

Funding & Sponsors
Funding source category [1] 3386 0
University
Name [1] 3386 0
The University of Newcastle
Country [1] 3386 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Area Health Service
Address
Lookout Road, New Lambton Heights NSW 2305.
Country
Australia
Secondary sponsor category [1] 3031 0
None
Name [1] 3031 0
Address [1] 3031 0
Country [1] 3031 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5417 0
Hunter New England Research Ethics Unit
Ethics committee address [1] 5417 0
Hunter Area Headquarters, Lookout Road, New Lambton Heights NSW 2305.
Ethics committee country [1] 5417 0
Australia
Date submitted for ethics approval [1] 5417 0
Approval date [1] 5417 0
05/05/2009
Ethics approval number [1] 5417 0
08/04/16/5.03

Summary
Brief summary
The primary purpose of this study is to investigate the effects of speech pathology treatment on chronic (persistent) cough. It is expected that the treatment will have a positive effect on cough by decreasing a person's cough sensitivity, frequency and severity and by increasing a person's cough quality of life.
Trial website
Trial related presentations / publications
Ryan NM, Vertigan AE, Bone SL, Gibson PG. Cough reflex sensitivity improves with speech language pathology management of refractory chronic cough. Cough. 2010;6:5.

Ryan NM, Vertigan AE, Bone SL, Gibson PG. Cough reflex sensitivity improves with speech language pathology management of refractory chronic cough [abstract]. Respirology. 2010;15(Suppl. 1):A37.

Cough reflex sensitivity improves with speech language pathology management of refractory chronic cough, Invited Oral, TSANZ, March 2010
Public notes

Contacts
Principal investigator
Name 28592 0
Prof Peter G Gibson
Address 28592 0
Level 2 West Wing, HMRI
Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305.
Country 28592 0
Australia
Phone 28592 0
+61240420142
Fax 28592 0
+61240420046
Email 28592 0
[email protected]
Contact person for public queries
Name 11749 0
Dr Nicole M Ryan
Address 11749 0
Level 2 West Wing, HMRI
Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305.
Country 11749 0
Australia
Phone 11749 0
+61240420123
Fax 11749 0
+61240420046
Email 11749 0
[email protected]
Contact person for scientific queries
Name 2677 0
Prof Peter G Gibson
Address 2677 0
Level 2 West Wing, HMRI
Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305.
Country 2677 0
Australia
Phone 2677 0
+612 40420142
Fax 2677 0
+612 40420046
Email 2677 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
Dimensions AICough reflex sensitivity improves with speech language pathology management of refractory chronic cough2010https://doi.org/10.1186/1745-9974-6-5
N.B. These documents automatically identified may not have been verified by the study sponsor.