Citric acid cough challenge validatio

Completed

• Conditions: Artificially induced cough; Signs and Symptoms; Cough

• Registration Number: ISRCTN98385033
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Healthy male/female volunteers
2. Male and female subjects of at least 18 years of age
3. Non-smokers or, ex-smokers of at least 12 months
4. Forced expiratory volume in one second (FEV1) greater than 80% of predicted

Exclusion Criteria

1. Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures
2. Suffering from any active seasonal allergies
3. Suffering from concomitant disease which may interfere with study procedures or evaluation.
4. Subjects suffering from gastroesophageal reflux taking proton pump inhibitors or any other regular antacid therapy
5. Subjects suffering from post nasal drip syndrome
6. A recent respiratory tract infection within 6 weeks prior to entry on to study
7. Use of medications known to alter the cough reflex
8. Smoking history of greater than 10 pack years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reproducibility of cough reflex sensitivity to citric acid (measured via inhalation of incremental, doubling concentrations of citric acid until the concentration inducing two or more coughs or five or more coughs is reached)using the modified Devilbiss 646 nebuliser powered by the KoKo DigiDoser. Measured within 1 day comparing baseline challenge and challenges at 1, 2 and 4 hours post-baseline to measure within-day reproducibility.

Secondary Outcome Measures

Name	Time	Method
To compare the reproducibility of cough reflex sensitivity using the modified Devilbiss 646 nebuliser powered by the KoKo DigiDoser with that of the more commonly used MB2 nebuliser powered by the MB3 mefar dosimeter. Assessed at baseline and then two weeks later to assess between-day reproducibility.