Chronic Obstructive Pulmonary Disease (COPD)MICANCT01701869
Microbiology & Immunology of the Chronically-inflamed Airway
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southampton University Hospital NHS Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: Microbiology & Immunology of the Chronically-inflamed Airway (RESP RES-001 (117027))
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.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of NTHi in radiologically-designated areas of disease in the COPD lung
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.
Measured: Within 2 years of enrollment
Measurement of NTHi specific antibody levels in lavage derived from radiologically-designated areas of disease in the COPD lung
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.
Measured: Within 2 years of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Tom MA Wilkinson, MA MB BS MRCP PhD, Study director, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701869
- Sponsor's protocol ID
- RMH MED 1055
- Other IDs
- RESP RES-001 (117027)
- Acronym
- MICA
- Status last verified
- Apr 2016
- First submitted
- 1 Oct 2012
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ostridge K, Williams N, Kim V, Bennett M, Harden S, Welch L, Bourne S, Coombs NA, Elkington PT, Staples KJ, Wilkinson TM. Relationship between pulmonary matrix metalloproteinases and quantitative CT markers of small airways disease and emphysema in COPD. Thorax. 2016 Feb;71(2):126-32. doi: 10.1136/thoraxjnl-2015-207428. Epub 2015 Dec 8.
PubMed 26645414Ostridge K, Williams N, Kim V, Harden S, Bourne S, Coombs NA, Elkington PT, Estepar RS, Washko G, Staples KJ, Wilkinson TM. Distinct emphysema subtypes defined by quantitative CT analysis are associated with specific pulmonary matrix metalloproteinases. Respir Res. 2016 Jul 26;17(1):92. doi: 10.1186/s12931-016-0402-z.
PubMed 27460105
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiology & Immunology of the Chronically-inflamed Airway (RESP RES-001 (117027))
- ClinicalTrials.gov ID
- NCT01701869
- Acronym / sponsor ID
- MICA / RMH MED 1055
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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].
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Results publication: PubMed 26645414Ostridge K, Williams N, Kim V, Bennett M, Harden S, Welch L, Bourne S, Coombs NA, Elkington PT, Staples KJ, Wilkinson TM. Relationship between pulmonary matrix metalloproteinases and quantitative CT markers of small airways disease and emphysema in COPD. Thorax. 2016 Feb;71(2):126-32. doi: 10.1136/thoraxjnl-2015-207428. Epub 2015 Dec 8.
- Derived from this study: PubMed 27460105Ostridge K, Williams N, Kim V, Harden S, Bourne S, Coombs NA, Elkington PT, Estepar RS, Washko G, Staples KJ, Wilkinson TM. Distinct emphysema subtypes defined by quantitative CT analysis are associated with specific pulmonary matrix metalloproteinases. Respir Res. 2016 Jul 26;17(1):92. doi: 10.1186/s12931-016-0402-z.
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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.
Tom MA Wilkinson, MA MB BS MRCP PhD study director
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 10 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection of NTHi in radiologically-designated areas of disease in the COPD lung (time frame: Within 2 years of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01701869, which also lists 2 linked publications.
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 14 Apr 2016.