Cough in Eastern and Central Finland

NCT ID: NCT03639727

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Citric acid aerosol bronchial challenge

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type ACTIVE_COMPARATOR

Mannitol aerosol bronchial challenge

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Citric acid aerosol bronchial challenge

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

Intervention Type DIAGNOSTIC_TEST

Mannitol aerosol bronchial challenge

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

(both criteria must be fulfilled)

* presence of current chronic cough (\> 8 weeks)
* Leicester Cough Questionnaire total score \< 17


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Heikki Koskela

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heikki O Koskela, MD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Pautola HVT, Koskela HO, Purokivi MK, Kaulamo JT, Latti AM. The prevalence and risk factors of respiratory symptoms in Finland: a comparative analysis. Eur Clin Respir J. 2025 Sep 25;12(1):2563395. doi: 10.1080/20018525.2025.2563395. eCollection 2025.

Reference Type DERIVED
PMID: 41020184 (View on PubMed)

Other Identifiers

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KUH5801136

Identifier Type: -

Identifier Source: org_study_id

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