Respiratory DisordersNCT01516437
A Study to Assess Immunity to Specific Microbial Antigens in Healthy Smokers and Non-smokers and in Subjects With Stable COPD
A study testing Blood collection, Swab collection and Sputum collection in people with Respiratory Disorders, run by GlaxoSmithKline at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disorders
- What is being tested?
- Blood collection, Swab collection and Sputum collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Feb 2012to 20 Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Liège, 4000
About this study
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
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
- Being tested
- Blood collection, Swab collection, Sputum collection
- Keywords
- Chronic Obstructive Pulmonary disease (COPD)
- Medical subject headings
- Respiration Disorders, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionProcedure or surgery
Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.
Swab collectionProcedure or surgery
Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).
Sputum collectionProcedure or surgery
Sputum collection at Day 0 and at exacerbation visits (COPD subjects)
| Study group | Role | What they receive |
|---|---|---|
| HNS Group | Experimental | Healthy non-smokers aged between 45-75 years Receives: Procedure: Blood collection; Procedure: Swab collection |
| HS Group | Experimental | Healthy smokers aged between 45-75 years Receives: 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 Receives: 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 Receives: Procedure: Blood collection; Procedure: Swab collection; Procedure: Sputum collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At Day 0
Anti-protein D Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: At Day 0
Anti-pneumolysin Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Measured: 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%.
Measured: 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%.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: At Day 0
Number of Subjects With Positive Sputum - Culture Testing Results
Measured: At Day 0
Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results
Measured: At Day 0
Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study start1 Feb 2012
- Primary completion28 Jun 2012
- Study completion20 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516437
- Sponsor's protocol ID
- 116021
- Status last verified
- Apr 2017
- First submitted
- 19 Jan 2012
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01516437
- Acronym / sponsor ID
- 116021
- Conditions
- Respiratory Disorders
- Keywords
- Chronic Obstructive Pulmonary disease (COPD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 28 Jun 2012 (actual)
- Study completion
- 20 Dec 2012 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Posted 7 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HNS Group | Experimental | Procedure: Blood collection, Procedure: Swab collectionHealthy non-smokers aged between 45-75 years |
| HS Group | Experimental | Procedure: Blood collection, Procedure: Swab collectionHealthy smokers aged between 45-75 years |
| FeCOPD Group | Experimental | Procedure: Blood collection, Procedure: Swab collection, Procedure: Sputum collectionCOPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years |
| NFeCOPD Group | Experimental | Procedure: Blood collection, Procedure: Swab collection, Procedure: Sputum collectionCOPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (43 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionBlood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response. | Procedure or surgery | FeCOPD Group, HNS Group, HS Group, NFeCOPD Group |
| Swab collectionNasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects). | Procedure or surgery | FeCOPD Group, HNS Group, HS Group, NFeCOPD Group |
| Sputum collectionSputum collection at Day 0 and at exacerbation visits (COPD subjects) | Procedure or surgery | FeCOPD Group, NFeCOPD Group |
Primary outcome
Anti-protein D Antibody Concentrations
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL)
Anti-protein D Antibody Concentrations
Time frame: At Month 6
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Anti-Pneumococcal Histidine Triad D Antibody Concentrations
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Anti-Pneumococcal Histidine Triad D Antibody Concentrations
Time frame: At Month 6
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Anti-pneumolysin Antibody Concentrations
Time frame: At Day 0
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.
Anti-pneumolysin Antibody Concentrations
Time frame: At Month 6
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Concentrations for Serum Protein-D Enzymatic Inhibition
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.
Concentrations for Serum Protein-D Enzymatic Inhibition
Time frame: At Month 6
Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.
Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%
Time frame: At Day 0
Concentrations were expressed as geometric mean concentrations (GMCs)
Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%
Time frame: At Month 6
Concentrations were expressed as geometric mean concentrations (GMCs)
5 secondary outcomes
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
Time frame: 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
Time frame: At Day 0
Number of Subjects With Positive Sputum - Culture Testing Results
Time frame: At Day 0
Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results
Time frame: At Day 0
Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results
Time frame: At Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection, Swab collection and Sputum collection in people with Respiratory Disorders, run by GlaxoSmithKline at 3 sites in Belgium.
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 15 inclusion and 43 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: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Anti-protein D Antibody Concentrations (time frame: At Day 0). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2017.