NCT05034367

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 1, 2021

Last Update Submit

September 6, 2024

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

  • Cough-to-dose ratio

    calculated as the number of coughs per 100 mg of total cumulative dose of mannitol

    Coughs are recorded during the 60 seconds after each mannitol dose

Study Arms (1)

Healthy persons

EXPERIMENTAL

The responses of the healthy subjects are utilized to create reference ranges for a normal cough response to mannitol

Diagnostic Test: Mannitol challenge

Interventions

Mannitol challengeDIAGNOSTIC_TEST

Inhalation challenge with dry powder of mannitol with a maximal cumulative dose of 635 mg

Healthy persons

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • % aged 18- 50 yrs, and 50 % aged 51 - 90 years

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

Location

Kuopio University Hospital

Kuopio, 70029, Finland

Location

Related Publications (1)

  • Nurmi HM, Latti AM, Koskela HO. The Cough Response to Inhaled Mannitol in Healthy Subjects. Lung. 2024 Nov 28;203(1):5. doi: 10.1007/s00408-024-00755-6.

    PMID: 39607505DERIVED

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 5, 2021

Study Start

January 17, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

AU(1)FI(1)