Cough in Eastern and Central Finland

February 11, 2019 updated by: Heikki Koskela, Kuopio University Hospital
Comparison of citric acid and mannitol cough provocation tests among subjects with chronic cough and healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70029
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Diagnostic test: Citric acid aerosol bronchial challenge
Inhalation challenge by citric acid aerosol to investigate the subject's cough sensitivity
Active Comparator: 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.
Diagnostic test: Mannitol aerosol bronchial challenge
Inhalation challenge by mannitol aerosol to investigate the subject's cough sensitivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within one week from the start of the study in each individual

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leicester Cough Questionnaire total score
Time Frame: The first study day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

University of Helsinki

Investigators

  • Principal Investigator: Heikki O Koskela, MD, Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 18, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5801136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Cough

Clinical Trials on Citric acid aerosol bronchial challenge

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe