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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
Trial acronym
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

Study type
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
Intervention code [3] 283729 0
Comparator / control treatment
Lactose with 0.5% alum potassium sulphate placebo, oral route with speech pathology 4 step intervention for chronic cough.
Control group

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 284209 0
Self funded/Unfunded
Name [1] 284209 0
Address [1] 284209 0
Country [1] 284209 0
Primary sponsor type
John Hunter Hospital
Lookout Road, New Lambton Heights, NSW, 2305.
Secondary sponsor category [1] 269166 0
Name [1] 269166 0
Address [1] 269166 0
Country [1] 269166 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 286171 0
Approval date [1] 286171 0
Ethics approval number [1] 286171 0

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

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
Country 33371 0
Phone 33371 0
Fax 33371 0
Email 33371 0
Contact person for public queries
Name 16618 0
Prof 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
Phone 16618 0
+6124985 5766
Fax 16618 0
+6124985 5850
Email 16618 0
Contact person for scientific queries
Name 7546 0
A/Prof 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
Phone 7546 0
Fax 7546 0
+6124985 5850
Email 7546 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary