Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-smokers

NCT02490358 | Completed DMC

• 1 other identifier: ENA003
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers to analyse biomarkers of inflammation

Conditions

COPD; Asthma

Outcome Measures

Primary Outcomes (1)

• Lipid metabolites in sputum cell homogenate from healthy smokers and smokers and ex-smokers with COPD.

  8 months

Study Arms (3)

1

Healthy smoking subjects

2

COPD smoking subjects

3

COPD ex-smoker subjects

Eligibility Criteria

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

Study Population

Up to 20 of each of the following populations will be recruited in this study: * Healthy smoking subjects * Smoking subjects with COPD * Ex-smoking subjects with COPD

You may qualify if:

• Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Be between 18 and 75 years of age, inclusive, at informed consent.
• Healthy as determined by a physician, based on medical history and physical examination.
• Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked).
• Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent.
• COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening:
• Post-bronchodilator FEV1/FVC ratio of \<0.7
• Post-bronchodilator FEV ≥40 % and ≤80 % of predicted normal values calculated using NHANES reference equations.

You may not qualify if:

• Upper or lower respiratory tract infection within 4 weeks of the screening visit.
• Positive test for alcohol at screening.
• Taking prescription medication in the 14 days before screening.
• Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded include, but are not limited to pipes, cigars and e-cigarettes.
• Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening
• Urinary cotinine levels at screening \< 30 ng/ml.
• Subject is mentally or legally incapacitated.
• Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO.
• Any other reason that the Investigator considers makes the subject unsuitable to participate.
• Upper or lower respiratory tract infection within 4 weeks of the screening visit.
• Positive test for alcohol at screening.
• Subjects who are unable to produce a total weight of at least 0.1g of selected sputum at screening.
• Subject is mentally or legally incapacitated.
• Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO.
• Any other reason that the Investigator considers makes the subject unsuitable to participate.

Sponsors & Collaborators

• Respivert Ltd: lead
• Babraham Institute Enterprise Limited: collaborator

Study Sites (1)

Unknown Facility

London, NW10 7EW, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ginny Norris, Dr

  Respivert Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: July 3, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

GB (1)