Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
54 participants
OBSERVATIONAL
2016-10-31
2017-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
COPD frequent exacerbators
Aged 65-85 years with a diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease criteria (post bronchodilator FEV1/FVC ratio \<0.70). Moderate to severe airflow limitation (FEV1 30-80% predicted). Patients have experienced 2 or more exacerbations requiring oral steroids/antibiotics treatment and/or hospitalisation in the previous 12 months.
Influenza Vaccination
COPD infrequent exacerbators
Aged 65-85 years with a diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease criteria (post bronchodilator FEV1/FVC ratio \<0.70). Moderate to severe airflow limitation (FEV1 30-80% predicted). Patients have experienced no more than 1 course of oral steroids/antibiotics and none exacerbations requiring hospital admission in the previous 12 months.
Influenza Vaccination
Healthy controls
Aged 65-85 years and do not have any symptoms of lung disease and have normal spirometry.
Influenza Vaccination
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Influenza Vaccination
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
We will also include healthy participants aged 65-85 years without symptoms of lung disease who opt to receive the annual influenza vaccine.
Exclusion Criteria
* Any history of allergies, suspected hypersensitivity and/or contraindication to vaccines (e.g egg protein allergy)
* Participation in another clinical trial (use of investigational product or device)
* Not on optimal treatment (COPD patients only)
* Current smokers, exhaled CO \>10 parts per million
* Clinical instability, defined as experiencing a COPD exacerbation less than 4 weeks prior to baseline visit, as indicated by treatment with systemic glucocorticosteroids and/or antibiotics and/or hospitalization (COPD only)
* An upper/lower respiratory tract infection e.g. common cold, sinus symptoms, pneumonia, which has not resolved four weeks prior to baseline visit
* Diagnosis of asthma and/or other relevant lung disease (e.g. history of primary or clinically significant bronchiectases, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease \[e.g. fibrosis, silicosis, sarcoidosis\], active tuberculosis)
* Known alpha-1-antitrypsin deficiency
* Immunological diseases or known infection with Human Immunodeficiency Virus (HIV)
* Any diagnosis of a malignant disease (other than basal or squamous cell carcinoma) in the last 5 years
* Currently taking immunosuppressive medications
* Diagnosis of diabetes mellitus
* Severe renal failure (calculated eGFR less than 60 ml/min)
* Liver impairment Child-Pugh B/C and/or active viral hepatitis
* Severe psychiatric or neurological disorders (Parkinson's disease or motor neurone disease)
* Planned donation of human tissue (blood, organs or bone marrow) during the course of the trial
65 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Kent
OTHER
NHS Lincolnshire West Clinical Commissioning Group
OTHER
NHS South Lincolnshire Clinical Commissioning Group
OTHER
University of Lincoln
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Arwel Jones
Research Fellow
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Glen Davison, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kent
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lincolnshire West CCG
Lincoln, , United Kingdom
South Lincolnshire CCG
Lincoln, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CoSREC192
Identifier Type: -
Identifier Source: org_study_id