Cough in Eastern and Central Finland
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges
Study Overview
Brief Summary
Comparison of citric acid and mannitol cough provocation tests among subjects with chronic cough and healthy volunteers.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Citric acid aerosol bronchial challenge
Inhaled citric acid aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is citric acid aerosol challenge.
Intervention: Citric acid aerosol bronchial challenge (Diagnostic Test)
Mannitol aerosol bronchial challenge
Inhaled mannitol aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is mannitol aerosol challenge.
Intervention: Mannitol aerosol bronchial challenge (Diagnostic Test)
Outcomes
Primary Outcomes
Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges
Time Frame: Within one week from the start of the study in each individual
Receiver operator characteristic curve describes the ability of the bronchial challenge to separate the cough patients from healthy volunteers
Secondary Outcomes
- Leicester Cough Questionnaire total score(The first study day)
Investigators
Heikki Koskela
Professor
Kuopio University Hospital