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Completed

NCT Number: NCT03639727

Cough in Eastern and Central Finland

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

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Key information

Conditions

Chronic Cough Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, 70029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citric acid aerosol bronchial challenge

Diagnostic Test

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

Mannitol aerosol bronchial challenge

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • University of Helsinki

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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