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Cough in Eastern and Central Finland

Cough in Eastern and Central Finland

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03639727
Enrollment
61
Registered
2018-08-21
Start date
2018-09-01
Completion date
2019-01-31
Last updated
2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Cough

Keywords

cough, cough provocation test, mannitol, citric acid

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.

Interventions

DIAGNOSTIC_TESTCitric acid aerosol bronchial challenge

Inhalation challenge by citric acid aerosol to investigate the subject's cough sensitivity

DIAGNOSTIC_TESTMannitol aerosol bronchial challenge

Inhalation challenge by mannitol aerosol to investigate the subject's cough sensitivity

Sponsors

University of Helsinki
CollaboratorOTHER
Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

This study compares citric acid and mannitol bronchial challenges in their ability to separate chronic cough subjects from healthy subjects. There are no therapeutic interventions.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challengesWithin one week from the start of the study in each individualReceiver operator characteristic curve describes the ability of the bronchial challenge to separate the cough patients from healthy volunteers

Secondary

MeasureTime frameDescription
Leicester Cough Questionnaire total scoreThe first study dayMeasures 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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026