Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03722849




Registration number
NCT03722849
Ethics application status
Date submitted
24/10/2018
Date registered
29/10/2018

Titles & IDs
Public title
Functional Magnetic Resonance Imaging of ATP Cough in Chronic Cough Patients
Scientific title
A Functional Magnetic Resonance Imaging Study to Investigate ATP-sensitive Cough Neural Pathways in Patients With Chronic Cough Hypersensitivity
Secondary ID [1] 0 0
Study 58136
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cough 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Adenosine Triphosphate
Treatment: Drugs - Capsaicin
Other interventions - Functional Brain Imaging

Experimental: Chronic cough participant - Twenty-five (25) Idiopathic chronic cough patients, defined as refractory to disease modifying therapies (eg anti-asthma medications), will be recruited.

Participants will attend two sessions. In the first they will inhale in a single breath a nebulized solutions of increasing doses of Adenosine Triphosphate (ATP; 0.2-300 milliM) and capsaicin (0.5-125 microM) to determine their individual cough and urge-to-cough thresholds. In the second session, participants will undergo functional brain imaging (fMRI) for 1 hour while inhaling over 24 seconds randomly administered nebulized solutions of saline, or threshold doses of ATP or capsaicin.

Experimental: Healthy control participant - Twenty-five (25) appropriately age and sex matched healthy non-smoking individuals will be recruited as the comparison group.

Participants will attend two sessions. In the first they will inhale in a single breath a nebulized solutions of increasing doses of ATP (0.2-300 milliM) and capsaicin (0.5-125 microM) to determine their individual cough and urge-to-cough thresholds. In the second session, participants will undergo fMRI for 1 hour while inhaling over 24 seconds randomly administered nebulized solutions of saline, or threshold doses of ATP or capsaicin.


Treatment: Drugs: Adenosine Triphosphate
Participants will inhale escalating concentrations of Adenosine Triphosphate (ATP) to induce cough and the urge-to-cough

Treatment: Drugs: Capsaicin
Participants will inhale escalating concentrations of capsaicin to induce cough and the urge-to-cough

Other interventions: Functional Brain Imaging
Participants will have scans of their brain activity using 3 Tesla (3T) brainstem restricted functional brain imaging (fMRI)
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Brainstem Neural Activations to Capsaicin
Timepoint [1] 0 0
fMRI was performed in a single session on the day of the cough challenge testing session and not more than seven days after.
Primary outcome [2] 0 0
Brainstem Neural Activations to ATP
Timepoint [2] 0 0
fMRI was performed in a single session on the day of the cough challenge testing session and not more than seven days after.
Secondary outcome [1] 0 0
Behavioral Responses During Cough Challenge Testing: Cough Sensitivity to Capsaicin
Timepoint [1] 0 0
Thresholds for cough sensitivity were measured during a 1 hr session prior to fMRI scanning
Secondary outcome [2] 0 0
Behavioral Responses During Cough Challenge Testing: Cough Sensitivity to ATP
Timepoint [2] 0 0
Thresholds for cough sensitivity were measured during a 1 hr session prior to fMRI scanning
Secondary outcome [3] 0 0
Behavioral Responses to Cough Challenge Testing: Urge to Cough Ratings to Capsaicin and ATP
Timepoint [3] 0 0
Urge-to-cough ratings were reported during the 1 hour cough challenge testing session and during the subsequent fMRI scanning session

Eligibility
Key inclusion criteria
* Patients with physician diagnosed chronic refractory cough (cough lasting >8 weeks).
* > 18 years of age
* Must be cognitively impaired
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* People with contraindications to MRI scanning (i.e. metal implants, claustrophobia).
* History of uncontrolled asthma or chronic respiratory disease (other than refractory cough).
* Evidence of an allergic reaction to capsaicin (chilli).
* Pregnant women.
* Smoking, current or recent history (last 6 months).

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2022
Sample size
Target
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The University of Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
3010 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Stuart Mazzone
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Imperial College London
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Queen's University, Belfast
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Stuart Mazzone, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be shared


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03722849