MCT and Capsaicin Provocation Challenge in Diagnosis of Chronic Cough

• Register: ClinicalTrials.gov
• Last refreshed on: 21 June 2021
• Main ID: NCT03363698
• Date of registration: 08/11/2017
• Prospective Registration: Yes
• Primary sponsor: Medical University of Warsaw
• Public title: MCT and Capsaicin Provocation Challenge in Diagnosis of Chronic Cough
• Scientific title: The Usefulness of the Methacholine Challenge Test and Capsaicin Inhalation Cough Challenge in a Prediction of Response to Management in Adults With a Chronic Cough.
• Date of first enrolment: December 31, 2020
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03363698
• Study type: Observational

Countries of recruitment

Poland

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adults patients aged between 18 and 75;

2. Chronic cough lasting more than 8 weeks;

3. Non-smoking (min. 6 months);

4. Not treated with angiotensin-converting enzyme (ACE) inhibitors;

5. Not treated with:

1. inhaled corticosteroids or systemic corticosteroids min. 4 weeks before
enrolment,

2. proton pump inhibitors min. 2 weeks before enrolment,

3. antihistaminic drugs 1 week before enrolment;

6. With normal chest radiograph or with insignificant changes in cough pathogenesis

7. Without airway infection in previous 6 weeks.

8. Patients enrolled with informed consent.

Exclusion Criteria:

1. Patients under 18 years old and above 75 years old;

2. Smokers (actual or ex-smokers shorter than 6 weeks);

3. Therapy with corticosteroids (inhaled or systemic) for last 4 weeks, proton pump
inhibitors for 2 weeks, antihistaminic drug for 1 week before enrolment;

4. Airway infection 6 weeks preceding enrolment or during study - re-attempt to enroll
after 6 weeks



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Allergic Rhinitis

Upper-Airway Cough Syndrome

Cough Variant Asthma

Cough

GERD

Intervention(s)

Other: Cough variant asthma treatment

Primary Outcome(s)

The decrease of a cough after cough variant asthma therapy measured by Visual Analogue Scale (VAS). [Time Frame: at least 4 weeks of treatment]

The decrease of a cough after cough variant asthma therapy measured by Leicester Cough Questionnaire (LCQ). [Time Frame: at least 4 weeks of treatment]

The decrease of a cough after cough variant asthma therapy measured by the cough challenge. [Time Frame: at least 4 weeks of treatment]

Secondary ID(s)

BHR in chronic cough

Source(s) of Monetary Support

Please refer to primary and secondary sponsors