Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01516437
First received: January 19, 2012
Last updated: February 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Respiratory Disorders
Procedure: Blood collection
Procedure: Swab collection
Procedure: Sputum collection
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Study to Assess Immunity to Specific Microbial Antigens in Healthy Smokers and Non-smokers and in Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD) Aged Between 45-75 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral immunity against specific microbial antigens [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
  • Humoral immunity against specific microbial antigens [ Time Frame: At Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cell-mediated immune responses against specific microbial antigens [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
  • Occurrence of specific bacterial pathogens in sputum [ Time Frame: At Day 0 and at exacerbation visits (Month 1 to Month 6) ] [ Designated as safety issue: No ]
  • Occurrence of specific bacterial pathogens in nasopharyngeal and oropharyngeal swabs [ Time Frame: At Day 0 and at exacerbation visits (Month 1 to Month 6) ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Healthy non-smokers aged between 45-75 years
Procedure: Blood collection
Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.
Procedure: Swab collection
Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).
Experimental: Group B
Healthy smokers aged between 45-75 years
Procedure: Blood collection
Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.
Procedure: Swab collection
Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).
Experimental: Group C
COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
Procedure: Blood collection
Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.
Procedure: Swab collection
Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).
Procedure: Sputum collection
Sputum collection at Day 0 and at exacerbation visits (COPD subjects)
Experimental: Group D
COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
Procedure: Blood collection
Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.
Procedure: Swab collection
Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).
Procedure: Sputum collection
Sputum collection at Day 0 and at exacerbation visits (COPD subjects)

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  • Known history of immune-mediated disorder.
  • Recent use of antibiotics or antiviral drug within 30 days prior to Screening Visit.
  • Pregnant female.
  • Other conditions that the investigator judges may interfere with study findings.

COPD subjects (frequent and non-frequent exacerbators)

  • Use of any investigational or non-registered product within 30 days prior to Screening Visit or planned use during the study. Use of investigational inhaled long acting muscarinic antagonists (LAMA), inhaled long acting beta agonists (LABA) or inhaled corticosteroids is allowed.
  • Concurrently participating in another clinical study in which the subject has been or will be exposed to an investigational or a non-investigational product. Subjects participating in clinical studies with investigational inhaled LAMA and/or LABA and/or inhaled corticosteroids can be enrolled.
  • 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.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • Serious, uncontrolled disease likely to interfere with the study findings.
  • 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.
  • Known history of immune-mediated disease other than COPD.
  • Recent use of antibiotics or antiviral drug within 30 days prior to Screening Visit.
  • Subject who experienced COPD exacerbation which required antibiotic, systemic corticosteroid or hospitalisation and which did not resolve at least one month prior to Screening Visit and at least 30 days following the last dose of oral corticosteroids.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 180 days preceding screening visit.
  • Subjects with very severe COPD, GOLD stage IV.
  • Primary diagnosis of asthma.
  • Other respiratory disorders such as sarcoidosis, tuberculosis, lung cancer, lung fibrosis, cystic fibrosis.
  • A known diagnosis of α-1 antitrypsin deficiency as underlying cause of COPD.
  • History of lung surgery.
  • Pregnant female.
  • Other conditions that the investigator judges may interfere with study findings.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516437

Locations
Belgium
GSK Investigational Site
Brussels, Belgium, 1000
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Liège, Belgium, 4000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01516437     History of Changes
Other Study ID Numbers: 116021
Study First Received: January 19, 2012
Last Updated: February 7, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by GlaxoSmithKline:
Chronic Obstructive Pulmonary disease (COPD)

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on November 25, 2014