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Healthy SmokersNCT00159302

Biomarkers of iNOS Activity in COPD, Asthma, Healthy Control

An observational study of Healthy Smokers and Healthy Non-smokers, run by Imperial College London at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Induced Sputum, Exhaled Nitric Oxide and Nasal Nitric Oxide
Type of treatment
Surgery or procedure
How many people
0 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2003to Sep 2006
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy volunteers (smokers)
  • 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.
  • Aged 40-75 years inclusive.
  • Male or female
  • Body mass index within the range 19-32kg/m2 inclusive.
  • Subject has a screening FEV1 measurement of > 80% of predicted
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  • Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • 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:
  • 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.
  • Aged 40-75 years inclusive.
  • Male or female
  • Body mass index within the range 19-32kg/m2 inclusive.
  • FEV1/FVC < 70%
  • FEV1 <15% reversibility (not % predicted) or an increase of <200ml (or both) after inhaled B2-agonists (400mcg salbutamol)
  • 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)
  • 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.
  • Male or female
  • Body mass index within the range 19-32kg/m2 inclusive.
  • Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • 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).
  • Aged 18 45 years
  • Baseline FEV1 > 70% of predicted
  • Non Smokers with no smoking history
  • PC20 methacholine < 8 mg/ml at screening
  • Subjects must have had positive skin prick test for 2 or more of common antigens in the past 2 years or at screening

Who cannot join

  • Healthy volunteers (smokers)
  • A healthy smoking subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
  • 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.
  • The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
  • The subject regularly, or on average, drinks more than 21 units per week
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  • 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.
  • The subject has received oral steroids within 3 months of study entry
  • The subject significant risk factors for Hepatitis B or C infection
  • 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:
  • As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
  • 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.
  • The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
  • The subject regularly, or on average, drinks more than 21 units per week
  • 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.
  • The subject has received oral steroids within 3 months of study entry.
  • The subject has history of an upper respiratory infection (including sinusitis) within 4 weeks prior to study entry.
  • The subject has been hospitalised for a COPD exacerbation within 3 months of study entry
  • 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
  • For the non-steroid group, inhaled steroid use is not permitted within 14 days of study entry until completion of the study
  • The subject significant risk factors for Hepatitis B or C infection
  • 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:
  • 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.
  • Subjects have a symptomatic pattern suggestive of poorly controlled asthma that in the opinion of the investigator precludes them from entry into the study
  • 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.
  • As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
  • 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.
  • The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
  • The subject regularly, or on average, drinks more than 21 units per week
  • 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.
  • The subject has received oral steroids within 3 months of study entry
  • The subject has history of a respiratory infection (including sinusitis) within 4 weeks prior to study entry
  • The subject has been hospitalised for a asthma exacerbation within 3 months of study entry
  • 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.
  • History of current or past drug or alcohol abuse.
  • 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.
  • Current or past smoking history.
  • The subject significant risk factors for Hepatitis B or C infection
  • The subject has significant risk factors for HIV infection.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

    London, SW3 6LY

Other trials in United Kingdom

About this study

Official title: 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

Read the 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.

Being tested
Induced Sputum, Exhaled Nitric Oxide, Nasal Nitric Oxide, Blood Tests, 24hr Urine Samples

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Induced SputumProcedure or surgery

  • Exhaled Nitric OxideProcedure or surgery

  • Nasal Nitric OxideProcedure or surgery

  • Blood TestsProcedure or surgery

  • 24hr Urine SamplesProcedure or surgery

  • Exhaled Breath CondensateProcedure or surgery

  • SpirometryProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startSep 2003
  3. Primary completionSep 2006
  4. Study completionSep 2006

Why it stopped: Lead Researcher left the Department

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00159302
Sponsor's protocol ID
RES11115
Status last verified
Jul 2019
First submitted
8 Sep 2005
Last updated
10 Jul 2019
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Smokers and Healthy Non-smokers, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00159302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.

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