Reference Ranges for the Cough Responsiveness to Inhaled Mannitol

Kuopio University Hospital

Status

Completed

Conditions

Cough

Treatments

Diagnostic Test: Mannitol challenge

Study type

Interventional

Funder types

Other

Identifiers

NCT05034367

5801151

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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