A Study to Assess Immunity to Specific Microbial Antigens in Healthy Smokers and Non-smokers and in Subjects With Stable COPD

NCT01516437 | Completed Results

• 1 other identifier: 116021
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

Brief Summary

The present study aims to assess the natural immunity to specific microbial antigens in healthy subjects and in subjects with stable COPD aged between 45-75 years.

Conditions

Respiratory Disorders

Keywords

Chronic Obstructive Pulmonary disease (COPD)

Outcome Measures

Primary Outcomes (10)

• Anti-protein D Antibody Concentrations

  Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL)

  At Day 0

• Anti-protein D Antibody Concentrations

  Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)

  At Month 6

• Anti-Pneumococcal Histidine Triad D Antibody Concentrations

  Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)

  At Day 0

• Anti-Pneumococcal Histidine Triad D Antibody Concentrations

  Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)

  At Month 6

• Anti-pneumolysin Antibody Concentrations

  The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.

  At Day 0

• Anti-pneumolysin Antibody Concentrations

  Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)

  At Month 6

• Concentrations for Serum Protein-D Enzymatic Inhibition

  Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.

  At Day 0

• Concentrations for Serum Protein-D Enzymatic Inhibition

  Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.

  At Month 6

• Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%

  Concentrations were expressed as geometric mean concentrations (GMCs)

  At Day 0

• Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%

  Concentrations were expressed as geometric mean concentrations (GMCs)

  At Month 6

Secondary Outcomes (5)

• Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation

  At Day 0

• Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation

  At Day 0

• Number of Subjects With Positive Sputum - Culture Testing Results

  At Day 0

• Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results

  At Day 0

• Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results

  At Day 0

Study Arms (4)

HNS Group

EXPERIMENTAL

Healthy non-smokers aged between 45-75 years

Procedure: Blood collection; Procedure: Swab collection

HS Group

EXPERIMENTAL

Healthy smokers aged between 45-75 years

Procedure: Blood collection; Procedure: Swab collection

FeCOPD Group

EXPERIMENTAL

COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years

Procedure: Blood collection; Procedure: Swab collection; Procedure: Sputum collection

NFeCOPD Group

EXPERIMENTAL

COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years

Procedure: Blood collection; Procedure: Swab collection; Procedure: Sputum collection

Interventions

Blood collection PROCEDURE

Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.

FeCOPD Group; HNS Group; HS Group; NFeCOPD Group

Swab collection PROCEDURE

Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).

FeCOPD Group; HNS Group; HS Group; NFeCOPD Group

Sputum collection PROCEDURE

Sputum collection at Day 0 and at exacerbation visits (COPD subjects)

FeCOPD Group; NFeCOPD Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects (smokers and non-smokers)
• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female between, and including 45 and 75 years of age at the time of consent.
• Written informed consent obtained from the subject.
• Baseline post-bronchodilator Forced Expiratory Volume of air in one second (FEV1) \> 85% of predicted normal values and baseline post-bronchodilator FEV1/Forced expiratory Vital Capacity (FVC) \> 70% of predicted normal values.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Non-smokers: subjects who never smoked OR
• Smokers: current smoker having a smoking history ≥ 10 pack-years.
• COPD subjects (frequent and non-frequent exacerbators)
• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female between, and including 45 and 75 years of age at the time of consent.
• Written informed consent obtained from the subject.
• Baseline post-bronchodilator FEV1 \< 80% and \>30% of predicted normal values and baseline post-bronchodilator FEV1/FVC \< 70% of predicted normal values.
• Current or former smoker having a smoking history of ≥ 10 pack-years.
• Documented history of ≥ one exacerbation within 365 days prior to the screening visit that required treatment with systemic corticosteroids or resulted in hospitalization.

You may not qualify if:

• Healthy subjects (smokers and non-smokers)
• Use of any investigational or non-registered product within 30 days prior to Screening Visit or planned use during the study.
• Concurrently participating in another clinical study in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Any known clinically significant anaemia or any other condition as per medical records that would preclude the drawing of blood as described in the protocol.
• Receipt of any vaccine within 30 days preceding blood sampling.
• Previous vaccination with any NTHi vaccine.
• Chronic administration of immunosuppressants or other immune-modifying drugs within 180 days prior to screening visit. Topical steroids are allowed.
• Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
• Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
• Any known respiratory disorders.
• Acute disease and/or fever at the time of the Screening Visit or Visit 1, as applicable
• Receipt of immunoglobulins and/or any blood products within 90 days prior to Screening Visit.
• Receipt of interferon within 90 days prior to Screening Visit.
• History of malignancy.
• Subjects with a history of, or current, alcohol or substance abuse.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Respiration Disorders; Pulmonary Disease, Chronic Obstructive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 24, 2012
• Study Start: February 1, 2012
• Primary Completion: June 28, 2012
• Study Completion: December 20, 2012
• Last Updated: May 17, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-04

Locations

BE (3)