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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05034367




Registration number
NCT05034367
Ethics application status
Date submitted
1/09/2021
Date registered
5/09/2021

Titles & IDs
Public title
Reference Ranges for the Cough Responsiveness to Inhaled Mannitol
Scientific title
Reference Ranges for the Cough Responsiveness to Inhaled Mannitol
Secondary ID [1] 0 0
5801151
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
Diagnosis / Prognosis - Mannitol challenge

Experimental: Healthy persons - The responses of the healthy subjects are utilized to create reference ranges for a normal cough response to mannitol


Diagnosis / Prognosis: Mannitol challenge
Inhalation challenge with dry powder of mannitol with a maximal cumulative dose of 635 mg
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cough-to-dose ratio
Timepoint [1] 0 0
Coughs are recorded during the 60 seconds after each mannitol dose

Eligibility
Key inclusion criteria
* age 18 years or older
* capable to understand the purpose of the study
* female/male ratio approximately 50%/50% in both of the following age groups:
* 50% aged 18- 50 yrs, and 50 % aged 51 - 90 years
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Current daily smoking
* Ex-smoking with a greater than 10 pack years' daily smoking history or with stopping of daily smoking less than one year ago
* Pregnancy and breastfeeding
* A doctor's diagnosis of any respiratory diseases, including both upper and lower airway diseases, lung parenchymal diseases and the sleep apnoea syndrome
* A doctor's diagnosis of gastro-oesophageal reflux disease or symptoms suggestive of it
* Current use of angiotensin-converting enzyme inhibitors
* Upper respiratory tract infection ('flu') within 4 weeks
* Any current (within 4 weeks) cough 8
* Chronic (over 2 months' duration) cough during the last 12 months
* Wheezing during the last 12 months
* Attacks of shortness of breath or cough at night during the last 12 months
* Symptoms of rhinitis in a prolonged fashion during the last 12 months
* Heartburn or regurgitation once a week or more often during the last 3 months
* Abnormal anatomy of the respiratory organs, which may affect the deposition of the mannitol powder
* Any previous operations to the respiratory organs that can affect the deposition of the mannitol powder
* Unable to provide written informed consent to participate in the study

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
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
Single group
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
17/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2023
Sample size
Target
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Kuopio

Funding & Sponsors
Primary sponsor type
Other
Name
Kuopio University Hospital
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
John Hunter Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Heikki O Koskela, MD
Address 0 0
Country 0 0
Phone 0 0
+358 447172795
Fax 0 0
Email 0 0
heikki.koskela@kuh.fi
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05034367