Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cough in Eastern and Central Finland

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03639727
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
University of Helsinki
Information provided by (Responsible Party):
Heikki Koskela, Kuopio University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Comparison of citric acid and mannitol cough provocation tests among subjects with chronic cough and healthy volunteers.

Condition or disease Intervention/treatment Phase
Chronic Cough Diagnostic Test: Citric acid aerosol bronchial challenge Diagnostic Test: Mannitol aerosol bronchial challenge Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cough in Eastern and Central Finland
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639727


Locations
Layout table for location information
Finland
Kuopio University Hospital
Kuopio, Finland, 70029
Sponsors and Collaborators
Kuopio University Hospital
University of Helsinki
Investigators
Layout table for investigator information
Principal Investigator: Heikki O Koskela, MD Kuopio University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Heikki Koskela, Professor, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT03639727    
Other Study ID Numbers: KUH5801136
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heikki Koskela, Kuopio University Hospital:
cough
cough provocation test
mannitol
citric acid
Additional relevant MeSH terms:
Layout table for MeSH terms
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Mannitol
Citric Acid
Sodium Citrate
Diuretics, Osmotic
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action