Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001186943
Ethics application status
Approved
Date submitted
15/11/2011
Date registered
15/11/2011
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pregabalin and Speech Pathology Treatment for Chronic Cough
Scientific title
Pregabalin and Speech pathology Treatment for Idiopathic and Refractory Chronic Cough: A Randomised Treatment Controlled Trial with the primary outcomes of cough quality of life and objective cough frequency.
Secondary ID [1] 273356 0
Nil
Universal Trial Number (UTN)
Trial acronym
PSPCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic and Refractory Chronic Cough 279133 0
Condition category
Condition code
Respiratory 279323 279323 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Pregabalin, Up to 3x75 mg per day for 12 weeks, maximum dose 300 mg/day, oral route
Arm 2: Speech pathology 4 step intervention for chronic cough, administered one on one with speech pathologist. Four steps include cough education, cough counselling, behavioural therapy such as swallowing technique, lifestyle intervention such as vocal hydration and at least one of these components will addressed at each visit depending on individual needs and understanding of the techniques by the participant. Each session will last for approximately 1 hour every 3 weeks for 12 weeks duration.
Intervention code [1] 283700 0
Treatment: Drugs
Intervention code [2] 283701 0
Behaviour
Intervention code [3] 283729 0
Lifestyle
Comparator / control treatment
Lactose with 0.5% alum potassium sulphate placebo, oral route with speech pathology 4 step intervention for chronic cough.
Control group
Placebo

Outcomes
Primary outcome [1] 279931 0
Cough quality of life by the Leicester Cough Questionnaire (LCQ)
Timepoint [1] 279931 0
Weeks 1, 2, 8, 14, 18.
Primary outcome [2] 279932 0
Cough frequency by Leicester Cough Monitor (LCM)
Timepoint [2] 279932 0
Weeks 1, 11, 18.
Primary outcome [3] 285957 0
Cough Reflex Sensitivity by single breath capsaicin testing
Timepoint [3] 285957 0
Weeks 1, 8, 14, 18.
Secondary outcome [1] 294847 0
Improvement in Voice Analysis by auditory perceptual voice analysis.
Timepoint [1] 294847 0
Weeks 2, 8, 14, 18.
Secondary outcome [2] 294853 0
Instrumental voice analysis using PRAAT.
Timepoint [2] 294853 0
Weeks 2, 8, 14, 18.
Secondary outcome [3] 294854 0
Voice measurement by electroglottography, and vocal loading task (lingwaves).
Timepoint [3] 294854 0
Weeks 2, 8, 14, 18.

Eligibility
Key inclusion criteria
Persistent cough lasting for 8 or more weeks that has not responded to medical treatment or persistent cough 8 or more weeks duration with no diagnosis.
Non-smoker or ex-smoker.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Productive cough with purulent sputum
Current smoker
Smoking related respiratory disease
Pregnant/Breast Feeding
Other active respiratory disease such as COPD
RTI during month prior to randomisation
Impaired liver function
Untreated asthma, reflux, rhinosinusitis
Psychiatric disorder or currently receiving medical treatment for psychiatric disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment-central randomisation by computer to pharmacy for active or placebo alocation to participant whom along with investigators are blinded to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2012
Actual
8/03/2012
Date of last participant enrolment
Anticipated
Actual
11/02/2014
Date of last data collection
Anticipated
Actual
25/06/2014
Sample size
Target
56
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284209 0
Self funded/Unfunded
Name [1] 284209 0
Country [1] 284209 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Road, New Lambton Heights, NSW, 2305.
Country
Australia
Secondary sponsor category [1] 269166 0
None
Name [1] 269166 0
Address [1] 269166 0
Country [1] 269166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286171 0
Hunter New England Research Ethics & Governance Unit
Ethics committee address [1] 286171 0
Hunter New England Local Health District Headquarters, Lookout Road, New Lambton Heights NSW 2305.
Ethics committee country [1] 286171 0
Australia
Date submitted for ethics approval [1] 286171 0
27/10/2011
Approval date [1] 286171 0
22/12/2011
Ethics approval number [1] 286171 0
11/11/13/3.04

Summary
Brief summary
The primary purpose of this study is to investigate and trial a combined therapy of novel medication and speech pathology for a persistent cough that hasn't previously responded to typical medical treatment. We will compare this program to individual component treatments of medication or speech pathology with the aim of significantly reducing cough symptoms and cough severity. Our ultimate goal is to resolve the cough resulting in a significant improvement in patient quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33371 0
A/Prof Anne Vertigan
Address 33371 0
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
14 Croudace Rd New Lambton
NSW 2310
Australia
Country 33371 0
Australia
Phone 33371 0
+61249213726
Fax 33371 0
Email 33371 0
[email protected]
Contact person for public queries
Name 16618 0
Professor Peter Gibson
Address 16618 0
Level 3 Hunter Medical Research Institute
Dept. Respiratory and Sleep Medicine
John Hunter Hospital, Lookout Road
New Lambton Heights, NSW, 2305.
Country 16618 0
Australia
Phone 16618 0
+6124985 5766
Fax 16618 0
+6124985 5850
Email 16618 0
[email protected]
Contact person for scientific queries
Name 7546 0
Anne Vertigan
Address 7546 0
Level 3 Hunter Medical Research Institute
Dept. Respiratory and Sleep Medicine
John Hunter Hospital, Lookout Road
New Lambton Heights, NSW, 2305.
Country 7546 0
Australia
Phone 7546 0
+61249213726
Fax 7546 0
+6124985 5850
Email 7546 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
EmbaseMechanisms and Rationale for Targeted Therapies in Refractory and Unexplained Chronic Cough.2021https://dx.doi.org/10.1002/cpt.2003
N.B. These documents automatically identified may not have been verified by the study sponsor.