Back to resultsReference Ranges for the Cough Responsiveness to Inhaled Mannitol
Primary Purpose
Cough
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mannitol challenge
Sponsored by
About this trial
This is an interventional diagnostic trial for Cough
Eligibility Criteria
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
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
Sites / Locations
- John Hunter HospitalRecruiting
- Kuopio University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy persons
Arm Description
The responses of the healthy subjects are utilized to create reference ranges for a normal cough response to mannitol
Outcomes
Primary Outcome Measures
Cough-to-dose ratio
calculated as the number of coughs per 100 mg of total cumulative dose of mannitol
Secondary Outcome Measures
Full Information
NCT ID
NCT05034367
First Posted
September 1, 2021
Last Updated
March 8, 2023
Sponsor
Kuopio University Hospital
Collaborators
John Hunter Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05034367
Brief Title
Reference Ranges for the Cough Responsiveness to Inhaled Mannitol
Official Title
Reference Ranges for the Cough Responsiveness to Inhaled Mannitol
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
John Hunter Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cough is the most common reason why people seek medical attention in developed countries. The main mechanisms for prolonged cough are hypersensitivity of the cough reflex arc, sputum production, and constriction of the airway smooth muscles. Recognition of the mechanism in each cough patient is essential for the efficient management of prolonged cough. At present, there are no feasible tests for everyday clinical work to recognize cough reflex arc hypersensitivity.
Mannitol test was originally developed for asthma diagnostics. We have recently shown that it can also be used to investigate hypersensitive cough reflex arc. The purpose of the present study is to create reference ranges for normal cough responsiveness to inhaled mannitol. Without them, the test cannot be utilized in everyday clinical work. For that purpose we will perform mannitol test in 140 subjects, who are at least 18 years old and without any chronic respiratory symptoms or disorders. The subjects will be recruited in three centers: University of Eastern Finland and: John Hunter Hospital in Australia.The material will be collected 1.9.2021-31.12.2023. We apply funding for both personnel and material expences, to carry out this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy persons
Arm Type
Experimental
Arm Description
The responses of the healthy subjects are utilized to create reference ranges for a normal cough response to mannitol
Intervention Type
Diagnostic Test
Intervention Name(s)
Mannitol challenge
Intervention Description
Inhalation challenge with dry powder of mannitol with a maximal cumulative dose of 635 mg
Primary Outcome Measure Information:
Title
Cough-to-dose ratio
Description
calculated as the number of coughs per 100 mg of total cumulative dose of mannitol
Time Frame
Coughs are recorded during the 60 seconds after each mannitol dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heikki O Koskela, MD
Phone
+358 447172795
Email
heikki.koskela@kuh.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna M Nurmi, MD
Phone
+358 447179973
Email
hanna.nurmi@kuh.fi
Facility Information:
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John D Brannan, PhD
Phone
+61 435 206 232
Email
john.brannan@health.nsw.gov.au
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heikki O Koskela, MD
Phone
+358 447172795
Email
heikki.koskela@kuh.fi
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Reference Ranges for the Cough Responsiveness to Inhaled Mannitol
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