Biomarkers of iNOS Activity in COPD, Asthma, Healthy Control

NCT00159302 | Withdrawn

• 1 other identifier: RES11115
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 flow rates. I

Conditions

Healthy Smokers; Healthy Non-smokers; Patients With Mild Asthma; Patints With COPD (GOLD II)

Interventions

Induced Sputum PROCEDURE

Exhaled Nitric Oxide PROCEDURE

Nasal Nitric Oxide PROCEDURE

Blood Tests PROCEDURE

24hr Urine Samples PROCEDURE

Exhaled Breath Condensate PROCEDURE

Spirometry PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 \[number of pack years = (number of cigarettes per day / 20) x number of years smoked\].
• 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.

You may not qualify if:

• Healthy volunteers (smokers)
• 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
• 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)
• 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.

Sponsors & Collaborators

• Imperial College London: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

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

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Sergei A Kharitonov, MD PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2003
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)