Biomarkers of iNOS Activity in COPD, Asthma, Healthy Control

July 8, 2019 updated by: Imperial College London

A Pilot Study to Evaluate and Develop Biomarkers of iNOS Activity in Patients With COPD or Asthma and Healthy Volunteers

This pilot study will measure the baseline levels and the intra- and inter-subject variability of exhaled (alveolar and bronchial) and nasal NO in smoking subjects with mild and moderate COPD on or off steroid treatment, smoking healthy volunteers and non-smoking mild asthmatics off steroids, using multiple exhalation flow rates.

I

Study Overview

Status

Status

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Withdrawn

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.

Detailed Description

n addition, exploratory markers of iNOS activity (eg. 3-nitrotyrosine, nitrite, nitrate and 3-nitro-4-hydoxyphenylacetic acid) in blood, sputum, urine and exhaled breath condensate will be evaluated. We will also evaluate exhaled and nasal NO in a population of mild asthmatics in order to obtain baseline and variability data for future clinical studies involving asthmatic subjects.

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

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
      • London, United Kingdom, SW3 6LY
        • Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy volunteers (smokers)

  1. Healthy subjects, defined as individuals who are free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, malignancy, endocrine, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
  2. Aged 40-75 years inclusive.
  3. Male or female
  4. Body mass index within the range 19-32kg/m2 inclusive.
  5. Subject has a screening FEV1 measurement of > 80% of predicted
  6. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  7. Smokers with a pack history >10 pack years [number of pack years = (number of cigarettes per day / 20) x number of years smoked].

A smoking COPD subject will be eligible for inclusion in this study only if all of the following criteria apply:

  1. COPD patients, defined as either Stage I or Stage II COPD diagnosis according to GOLD criteria Individuals must be otherwise healthy, individuals who are free from significant cardiac, gastrointestinal, hepatic, renal, haematological, malignancy, endocrine, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
  2. Aged 40-75 years inclusive.
  3. Male or female
  4. Body mass index within the range 19-32kg/m2 inclusive.
  5. FEV1/FVC < 70%
  6. FEV1 <15% reversibility (not % predicted) or an increase of <200ml (or both) after inhaled B2-agonists (400mcg salbutamol)
  7. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

9. An active smoker with a pack history of >10 pack years [number of pack years = (number of cigarettes per day / 20) x number of years smoked].

Asthma (non-smokers)

  1. Individuals must be otherwise healthy, individuals who are free from significant cardiac, gastrointestinal, hepatic, renal, haematological, malignancy, endocrine, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
  2. Male or female
  3. Body mass index within the range 19-32kg/m2 inclusive.
  4. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  5. Subjects with a history of non-severe allergic asthma and who are not receiving treatment in the form of inhaled or oral corticosteroids. Their history of asthma must be documented for a minimum of 6 months prior to entry to the study, with exclusion of other significant pulmonary diseases (i.e. chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis, and bronchopulmonary dysplasia).
  6. Aged 18 45 years
  7. Baseline FEV1 > 70% of predicted
  8. Non Smokers with no smoking history
  9. PC20 methacholine < 8 mg/ml at screening
  10. Subjects must have had positive skin prick test for 2 or more of common antigens in the past 2 years or at screening

Exclusion Criteria:

Healthy volunteers (smokers)

A healthy smoking subject will not be eligible for inclusion in this study if any of the following criteria apply:

  1. As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
  2. The subject has participated in a study with a new molecular entity during the previous 4 months or any other clinical trial during the previous 3 months. In case of a non invasive, clinical trial not involving new molecular entities a 1 month washout will be sufficient.
  3. The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
  4. The subject regularly, or on average, drinks more than 21 units per week
  5. The subjects is taking any medication (whether prescribed or over-the-counter), any herbal medication (incl. St.John's Wort) or high doses of nutritional supplements which could interfere with the study tests, within 14 days of study entry and throughout the study.
  6. The subject has received oral steroids within 3 months of study entry
  7. The subject significant risk factors for Hepatitis B or C infection
  8. The subject has significant risk factors for HIV infection.

COPD (smokers)

A smoking COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:

  1. As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
  2. The subject has participated in a study with a new molecular entity during the previous 4 months or any other clinical drug trial during the previous 3 months. In case of a non invasive, clinical trial not involving new molecular entities a 1 month washout will be sufficient.
  3. The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
  4. The subject regularly, or on average, drinks more than 21 units per week
  5. The subjects is taking any medication (whether prescribed or over-the-counter), any herbal medication (incl. St.John's Wort) or high doses of nutritional supplements which could interfere with the study tests, within 14 days of study entry and throughout the study.
  6. The subject has received oral steroids within 3 months of study entry.
  7. The subject has history of an upper respiratory infection (including sinusitis) within 4 weeks prior to study entry.
  8. The subject has been hospitalised for a COPD exacerbation within 3 months of study entry
  9. Subject is unable to abstain from xanthines (theophylline), inhaled long acting beta-2 agonists and tiotropium from 4 hours prior to first study visit until completion of study visit
  10. For the non-steroid group, inhaled steroid use is not permitted within 14 days of study entry until completion of the study
  11. The subject significant risk factors for Hepatitis B or C infection
  12. The subject has significant risk factors for HIV infection. Asthma (non-smokers)

A non smoking asthmatic subject will not be eligible for inclusion in this study if any of the following criteria apply:

  1. The subject has a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with either hypercapnoea, respiratory arrest or hypoxia seizures.
  2. Subjects have a symptomatic pattern suggestive of poorly controlled asthma that in the opinion of the investigator precludes them from entry into the study
  3. The subject received inhaled steroid within 14 days of study entry. Any subject who needs inhaled, intranasal or topical steroids between screening and study start should not be included in the study.
  4. As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
  5. The subject has participated in a study with a new molecular entity during the previous 4 months or any other clinical drug trial during the previous 3 months. In case of a non invasive, clinical trial not involving new molecular entities a 1 month washout will be sufficient.
  6. The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
  7. The subject regularly, or on average, drinks more than 21 units per week
  8. The subjects is taking any medication (whether prescribed or over-the-counter), any herbal medication (incl. St.John's Wort) or high doses of nutritional supplements which could interfere with the study tests, within 14 days of study entry and throughout the study.
  9. The subject has received oral steroids within 3 months of study entry
  10. The subject has history of a respiratory infection (including sinusitis) within 4 weeks prior to study entry
  11. The subject has been hospitalised for a asthma exacerbation within 3 months of study entry
  12. The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen or a positive medical history for hepatitis C antibody or hepatitis B surface antigen.
  13. History of current or past drug or alcohol abuse.
  14. Subject is unable to abstain from xanthines (theophylline), inhaled long acting beta-2 agonists and tiotropium from 4 hours prior to first study visit until completion of study visit.
  15. Current or past smoking history.
  16. The subject significant risk factors for Hepatitis B or C infection
  17. The subject has significant risk factors for HIV infection.

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

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.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

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: Sergei A Kharitonov, MD PhD, Imperial College London

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 (Actual)

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.
September 1, 2003

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.
September 1, 2006

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.
September 1, 2006

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).
September 8, 2005

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.
September 8, 2005

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.
September 12, 2005

Study Record Updates

Last Update Posted (Actual)

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.
July 10, 2019

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.
July 8, 2019

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.
July 1, 2019

More Information

Terms related to this study

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.
  • RES11115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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