Cough in Eastern and Central Finland

NCT03639727 | Completed

• 1 other identifier: KUH5801136
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Cough

Keywords

cough; cough provocation test; mannitol; citric acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Leicester Cough Questionnaire total score

  The first study day

Study Arms (2)

Citric acid aerosol bronchial challenge

ACTIVE COMPARATOR

Inhaled citric acid aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is citric acid aerosol challenge.

Diagnostic Test: Citric acid aerosol bronchial challenge

Mannitol aerosol bronchial challenge

ACTIVE COMPARATOR

Inhaled mannitol aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is mannitol aerosol challenge.

Diagnostic Test: Mannitol aerosol bronchial challenge

Interventions

Citric acid aerosol bronchial challenge DIAGNOSTIC_TEST

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

Citric acid aerosol bronchial challenge

Mannitol aerosol bronchial challenge DIAGNOSTIC_TEST

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

Mannitol aerosol bronchial challenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (both criteria must be fulfilled)
• presence of current chronic cough (\> 8 weeks)
• Leicester Cough Questionnaire total score \< 17
• absence of any form of cough

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, 70029, Finland

Location

Related Publications (1)

• 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.

  PMID: 41020184 DERIVED

MeSH Terms

Conditions

Chronic Cough; Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Heikki O Koskela, MD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 21, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)