Microbiology & Immunology of the Chronically-inflamed Airway (MICA)
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ClinicalTrials.gov Identifier: NCT01701869 |
Recruitment Status :
Completed
First Posted : October 5, 2012
Last Update Posted : April 14, 2016
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Condition or disease |
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Chronic Obstructive Pulmonary Disease (COPD) |
Study Type : | Observational |
Actual Enrollment : | 57 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Microbiology & Immunology of the Chronically-inflamed Airway (RESP RES-001 (117027)) |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |
Group/Cohort |
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NTHi positive
No intervention, this is an observational study
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NTHi negative
No intervention, this is an observational study
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Healthy Control
No intervention, this is an observational study
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- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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**

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701869
United Kingdom | |
Southampton University Hospital NHS Trust | |
Southampton, Hampshire, United Kingdom, SO16 6YD |
Study Director: | Tom MA Wilkinson, MA MB BS MRCP PhD | University of Southampton |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital Southampton NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT01701869 |
Other Study ID Numbers: |
RMH MED 1055 RESP RES-001 (117027) ( Other Grant/Funding Number: GSK Abbreviated title and eTrack study number ) |
First Posted: | October 5, 2012 Key Record Dates |
Last Update Posted: | April 14, 2016 |
Last Verified: | April 2016 |
Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases |