Cough in Eastern and Central Finland

Chronic Cough Clinical Trial

Official title:

Cough in Eastern and Central Finland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639727
• Other study ID #: KUH5801136
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of citric acid and mannitol cough provocation tests among subjects with chronic cough and healthy volunteers.

Description:

35 subjects with chronic cough plus 25 subjects without any cough will be asked to participate. The study consists of two visits in the outpatient clinic of Kuopio University Hospital, department of respiratory medicine, 2 - 7 days apart. They will fill in the Leicester Cough Questionnaire and undergo two different cough provocation tests, in random order: Mannitol test and citric acid test. If a chest x-ray has not been taken within 6 months, it will be taken.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria, Chronic cough patients:

(both criteria must be fulfilled)

• presence of current chronic cough (> 8 weeks)

• Leicester Cough Questionnaire total score < 17

Inclusion criteria, healthy volunteers

• absence of any form of cough

Exclusion Criteria:

• age < 18 years

• any disability which would challenge the subject's ability to understand the purpose and methods of the study

• pregnancy

• breastfeeding

• current smoking or ex smoking more than 10 pack years

• any thoracic x-ray finding indicating urgent mediacal interventions

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Diagnostic Test:
• Citric acid aerosol bronchial challenge
Inhalation challenge by citric acid aerosol to investigate the subject's cough sensitivity
• Mannitol aerosol bronchial challenge
Inhalation challenge by mannitol aerosol to investigate the subject's cough sensitivity

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges	Receiver operator characteristic curve describes the ability of the bronchial challenge to separate the cough patients from healthy volunteers	Within one week from the start of the study in each individual
Secondary	Leicester Cough Questionnaire total score	Measures cough-spesific quality of life. Range is 3 - 21 with low total score indicating poor cough-spesific quality of life. The three Leicester Cough Questionnaire subscales are added together to form the total score.	The first study day