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Microbiology & Immunology of the Chronically-inflamed Airway (MICA)

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.
 
ClinicalTrials.gov Identifier: NCT01701869
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Tracking Information
First Submitted Date October 1, 2012
First Posted Date October 5, 2012
Last Update Posted Date April 14, 2016
Study Start Date September 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 5, 2012)
  • Detection of NTHi in radiologically-designated areas of disease in the COPD lung [ Time Frame: Within 2 years of enrollment ]
    The overall aim of this project is to enhance our understanding of the relevance of local immunity to protection of the airway from viral and bacterial infection and thus development of vaccines against such organisms.
  • Measurement of NTHi specific antibody levels in lavage derived from radiologically-designated areas of disease in the COPD lung [ Time Frame: Within 2 years of enrollment ]
    The overall aim of this project is to enhance our understanding of the relevance of local immunity to protection of the airway from viral and bacterial infection and thus development of vaccines against such organisms.
Original Primary Outcome Measures
 (submitted: October 4, 2012)
Correlation of specific antibody concentrations in lavage samples with the presence or absence of NTHi [ Time Frame: Within 2 years of enrollment ]
The overall aim of this project is to enhance our understanding of the relevance of local immunity to protection of the airway from viral and bacterial infection and thus development of vaccines against such organisms.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Microbiology & Immunology of the Chronically-inflamed Airway
Official Title Microbiology & Immunology of the Chronically-inflamed Airway (RESP RES-001 (117027))
Brief Summary Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and the only one of the common causes that is still rising. The main effects of the disease are the destruction and inflammation of lung tissue rendering breathing difficult. COPD has significant effects on the quality of life of sufferers and the disease is predicted to be the fifth most common cause of disability in the world by 2020. Patients with COPD are prone to periods of worsening disease symptoms, known as exacerbations, which are often caused by viral and bacterial infections of the lung and current vaccines appear to have little efficacy in limiting these exacerbations. The loss of lung function caused by infectious exacerbations is irreversible and patients who frequently exacerbate experience more rapid disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species that colonises the airways and causes exacerbations in COPD. With the development of more sensitive molecular techniques it has been possible to ascertain that it is the acquisition of new strains of NTHi that correlate strongly with exacerbations. However, not all patients with COPD have NTHi in their lungs and the question remains as to why some COPD patients are susceptible to such infections. This study aims to answer this question by comparing the airways of COPD patients who are colonized by NTHi and those who are not to analyse whether the levels of protective antibodies in the lungs and the function of the immune cells in the NTHi colonized airway are reduced. Moreover, we aim to correlate this reduction in immunity with areas of lung damage ascertained by high resolution computed tomography. The aim of this research is to better understand this apparent deficiency in airway immunity as this is likely to impact on vaccine efficacy in COPD.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, plasma, inflammatory cell RNA/DNA, nasopharyngeal swabs, urine, sputum supernatants, sputum cells, bronchial epitehlial cells, BAL supernatants, BAL cells, bronchial biopsies.
Sampling Method Non-Probability Sample
Study Population Volunteers will be recruited from General Practice in the form of patient screening clinics,and GP Mailshot. Quitters and pulmonary rehabilitation, would also be approached. The Respiratory Centre, patient support groups, and outpatient departments and wards, would also be areas of recruitment.
Condition Chronic Obstructive Pulmonary Disease (COPD)
Intervention Not Provided
Study Groups/Cohorts
  • NTHi positive
    No intervention, this is an observational study
  • NTHi negative
    No intervention, this is an observational study
  • Healthy Control
    No intervention, this is an observational study
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 13, 2016)
57
Original Estimated Enrollment
 (submitted: October 4, 2012)
24
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Male or female subjects between, and including, 40 and 85 years of age, at the time of consent.
  • Subjects with confirmed diagnosis of COPD (based on postbronchodilator spirometry). [GOLD, 2009] with FEV1 of >80% (mild COPD) or >50% but ≤80% (moderate COPD) of predicted normal and FEV1/FVC<0.7
  • Subjects have mild or moderate COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging [GOLD, 2009].
  • Subjects have a current or prior history of ≥10 pack years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked.
  • Subjects with recent COPD exacerbations, in stable condition, and having stopped antibiotics, can be enrolled one month post exacerbation.

Exclusion Criteria:

  • Subject also has a confirmed diagnosis of asthma (as only cause of obstructive respiratory disorder), cystic fibrosis, pneumonia risk factors (e.g., HIV, Lupus, Parkinson's, Myasthenia Gravis) or other respiratory disorders (e.g., tuberculosis, lung cancer).
  • Subjects having undergone lung surgery
  • Subject has a α1-antitrypsin deficiency as underlying cause of COPD.
  • Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids (subjects can be enrolled when their acute AECOPD or pneumonia has resolved).
  • Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit.
  • Subject has other conditions that the principal investigator judges may interfere with the study findings, such as:
  • Subject at risk of noncompliance, or unable to comply with the study procedures.
  • Evidence of alcohol or drug abuse.
  • Others, as per clinical judgement
  • Women who are pregnant or lactating or are planning on becoming pregnant during the study **If subject has any ONE of the above exclusion they cannot be enrolled into the study**
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01701869
Other Study ID Numbers RMH MED 1055
RESP RES-001 (117027) ( Other Grant/Funding Number: GSK Abbreviated title and eTrack study number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University Hospital Southampton NHS Foundation Trust
Original Responsible Party Same as current
Current Study Sponsor University Hospital Southampton NHS Foundation Trust
Original Study Sponsor Same as current
Collaborators GlaxoSmithKline
Investigators
Study Director: Tom MA Wilkinson, MA MB BS MRCP PhD University of Southampton
PRS Account University Hospital Southampton NHS Foundation Trust
Verification Date April 2016