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Novel Endpoints in Cough Challenge Testing

Novel Endpoints in Cough Challenge Testing.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01566968
Acronym
NEAT
Enrollment
98
Registered
2012-03-30
Start date
2011-01-31
Completion date
2012-04-30
Last updated
2012-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Chronic Cough, Chronic Obstructive Pulmonary Disease, Healthy, Smokers

Keywords

COPD, Asthma, Healthy volunteers, Chronic cough, Smokers, Cough challenge, Cough challenge testing.

Brief summary

The sensitivity of a person's cough reflex can be measured by getting them to breathe in (inhale) irritant chemicals. There are different methods by which subjects are asked to inhale these chemicals, either by taking one deep breath in, or by asking them to just continue to take a number of breaths. The purpose of this clinical research study is to see if the coughing responses are different in healthy people and people with respiratory problems that make them cough when they are given these chemicals in these two methods.

Interventions

OTHERCough challenge test

Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.

OTHER24 hour ambulatory cough recording

Cough recording by using an ambulatory sound recording device.

OTHERCough quality of life questionnaire

questionnaire designed to assess impact of cough on a person's life

Sponsors

Manchester University NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult subjects aged 18 and over. Meet criteria for subject groups as outlined below: Healthy volunteers: * Must be non smokers. * No history of respiratory disease. Healthy smokers: * Current smokers with at least 10 pack year history of smoking. * Spirometry within normal limits i.e. FEV1 \> 80% predicted and FEV1/FVC ratio of \> 75% predicted. Asthma: * Physician diagnosis of asthma * Stable asthma. * Airway hyperresponsiveness to methacoline; PC20\< 16mg/ml. * Non smokers or ex-smokers with smoking history of less than 10 pack years. COPD: * Physician diagnosis of COPD * Ex smokers with smoking history of at least 20 pack years * Spirometry demonstating evidence of airflow obstruction i.e. FEV1/FVC ratio of \< 70% Chronic cough: * History of dry cough for at least 8 weeks. * Normal chest x ray. * Non smokers or ex smokers of less than 10 pack years history of smoking.

Exclusion criteria

* Symptoms of upper respiratory tract infection within the last 4 weeks. * Participation in another clinical trial of an investigational drug within 4 weeks. * Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate. * Patients with severe respiratory disease i.e. FEV1 \< 1.0 litre. * Use of steroid tablets in previous 2 months or taken more than 3 courses of steroid tablets in the preceding 12 months in subjects with asthma or COPD. * Change in asthma treatment in the preceding 6 weeks in asthma group * Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026