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Cough in Eastern and Central Finland

Primary Purpose

Chronic Cough

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Citric acid aerosol bronchial challenge
Mannitol aerosol bronchial challenge
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Cough focused on measuring cough, cough provocation test, mannitol, citric acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Citric acid aerosol bronchial challenge

Mannitol aerosol bronchial challenge

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Leicester Cough Questionnaire total score
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.

Full Information

First Posted
August 9, 2018
Last Updated
February 11, 2019
Sponsor
Kuopio University Hospital
Collaborators
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT03639727
Brief Title
Cough in Eastern and Central Finland
Official Title
Cough in Eastern and Central Finland
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough
Keywords
cough, cough provocation test, mannitol, citric acid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citric acid aerosol bronchial challenge
Arm Type
Active Comparator
Arm Description
Inhaled citric acid aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is citric acid aerosol challenge.
Arm Title
Mannitol aerosol bronchial challenge
Arm Type
Active Comparator
Arm Description
Inhaled mannitol aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is mannitol aerosol challenge.
Intervention Type
Diagnostic Test
Intervention Name(s)
Citric acid aerosol bronchial challenge
Intervention Description
Inhalation challenge by citric acid aerosol to investigate the subject's cough sensitivity
Intervention Type
Diagnostic Test
Intervention Name(s)
Mannitol aerosol bronchial challenge
Intervention Description
Inhalation challenge by mannitol aerosol to investigate the subject's cough sensitivity
Primary Outcome Measure Information:
Title
Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges
Description
Receiver operator characteristic curve describes the ability of the bronchial challenge to separate the cough patients from healthy volunteers
Time Frame
Within one week from the start of the study in each individual
Secondary Outcome Measure Information:
Title
Leicester Cough Questionnaire total score
Description
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.
Time Frame
The first study day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heikki O Koskela, MD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Cough in Eastern and Central Finland

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