Novel Endpoints in Cough Challenge Testing (NEAT)

April 5, 2012 updated by: Manchester University NHS Foundation Trust

Novel Endpoints in Cough Challenge Testing.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M23 9LT
        • University Hospital of South Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Selected from secondary care.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Volunteers
Adults between ages of 18-75 inclusive who have never smoked and have no history of any respiratory disease for which they are on regular treatment.
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life
Asthma
Adults between the ages on 18-75 inclusive who have a physician diagnosis of asthma and have no smoking history or minimal smoking history (less than 10 pack years or in other words less than 20 cigarettes per day for 10 years).
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life
COPD
Adults between the ages of 18-75 inclusive who have previously been smokers (at least 20 pack years) and have physician diagnosis and spirometry evidence of COPD.
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life
Healthy smokers
Adults between the ages of 18-75 inclusive who are currently smokers (at least 10 pack years history)but have no history of any respiratory disease and no evidence of COPD on spirometry.
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life
Chronic cough
Adults between ages of 18-75 inclusive who have history of dry cough for at least 8 weeks and have a normal chest x ray and no smoking history or minimal smoking history (less than 10 pack years).
Other: Cough challenge test
Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
Other: 24 hour ambulatory cough recording
Cough recording by using an ambulatory sound recording device.
Other: Cough quality of life questionnaire
questionnaire designed to assess impact of cough on a person's life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Manchester University NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saifudin Khalid, MRCP, University Hospital of South Manchester
  • Study Chair: Ashley Woodcock, MD, University Hospital of South Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEAT Version 2, 18/03/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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