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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
Not applicable
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