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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:
ClinicalTrials.gov Identifier:
NCT01516437
First Posted: January 24, 2012
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: January 10, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Respiratory Disorders
Interventions: Procedure: Blood collection
Procedure: Swab collection
Procedure: Sputum collection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. 3 enrolled subjects did not receive subject allocations, and were excluded from the study prior to start.

Reporting Groups
  Description
HNS Group Healthy non-smokers aged between 45-75 years
HS Group Healthy smokers aged between 45-75 years
FeCOPD Group COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
NFeCOPD Group COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years

Participant Flow:   Overall Study
    HNS Group   HS Group   FeCOPD Group   NFeCOPD Group
STARTED   24   24   15   7 
COMPLETED   24   24   14   6 
NOT COMPLETED   0   0   1   1 
Reason not specified                0                0                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HNS Group Healthy non-smokers aged between 45-75 years
HS Group Healthy smokers aged between 45-75 years
FeCOPD Group COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
NFeCOPD Group COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
Total Total of all reporting groups

Baseline Measures
   HNS Group   HS Group   FeCOPD Group   NFeCOPD Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   24   15   7   70 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (10.10)   57.8  (8.45)   64.1  (7.39)   61.4  (6.75)   60.26  (8.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      16  66.7%      9  37.5%      6  40.0%      2  28.6%      33  47.1% 
Male      8  33.3%      15  62.5%      9  60.0%      5  71.4%      37  52.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Anti-protein D Antibody Concentrations   [ Time Frame: At Day 0 ]

2.  Primary:   Anti-protein D Antibody Concentrations   [ Time Frame: At Month 6 ]

3.  Primary:   Anti-Pneumococcal Histidine Triad D Antibody Concentrations   [ Time Frame: At Day 0 ]

4.  Primary:   Anti-Pneumococcal Histidine Triad D Antibody Concentrations   [ Time Frame: At Month 6 ]

5.  Primary:   Anti-pneumolysin Antibody Concentrations   [ Time Frame: At Day 0 ]

6.  Primary:   Anti-pneumolysin Antibody Concentrations   [ Time Frame: At Month 6 ]

7.  Primary:   Concentrations for Serum Protein-D Enzymatic Inhibition   [ Time Frame: At Day 0 ]

8.  Primary:   Concentrations for Serum Protein-D Enzymatic Inhibition   [ Time Frame: At Month 6 ]

9.  Primary:   Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%   [ Time Frame: At Day 0 ]

10.  Primary:   Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%   [ Time Frame: At Month 6 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   Number of Subjects With Positive Sputum - Culture Testing Results   [ Time Frame: At Day 0 ]

14.  Secondary:   Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results   [ Time Frame: At Day 0 ]

15.  Secondary:   Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results   [ Time Frame: At Day 0 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01516437     History of Changes
Other Study ID Numbers: 116021
First Submitted: January 19, 2012
First Posted: January 24, 2012
Results First Submitted: January 10, 2017
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017