Pulmonary Disease, Chronic ObstructiveNCT02900209
Influenza Vaccination and COPD Phenotypes
An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Lincoln at 2 sites in United Kingdom.
Trial summary
The aim of this study is to determine responses of the immune system to the annual flu vaccination in people with COPD who experience frequent or infrequent exacerbations and healthy participants. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Influenza Vaccination
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 54 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2016to Sep 2017
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients 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) and moderate to severe airflow limitation (FEV1 30-80% predicted) will be approached. We will also include healthy participants as a control reference group who are aged 65-85 years without symptoms of lung disease and have normal spirometry.
Who may be able to join
- Patients 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) and moderate to severe airflow limitation (FEV1 30-80% predicted) who opt to receive the annual influenza vaccine.
- We will also include healthy participants aged 65-85 years without symptoms of lung disease who opt to receive the annual influenza vaccine.
Who cannot join
- Unable/unwilling to provide informed consent
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Lincolnshire West CCG
Lincoln
South Lincolnshire CCG
Lincoln
About this study
Official title: Responses of the Immune System to Influenza Vaccination in Phenotypes of Chronic Obstructive Pulmonary Disease
The aim of this study is to determine responses of the immune system to the annual flu vaccination in people with COPD who experience frequent or infrequent exacerbations and healthy participants. We will collect blood and saliva immediately before and one month after flu vaccination at GP surgeries in the Autumn/Winter period. By measuring how quickly antibodies (that provide protection against infection) develop in the blood after vaccination we can provide important new information to help confirm whether those prone to COPD flare ups have weaker immune systems.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Influenza Vaccination
- Keywords
- Influenza, Exacerbations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccinationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: Influenza Vaccination | |
| Healthy controls | Aged 65-85 years and do not have any symptoms of lung disease and have normal spirometry. Receives: Other: Influenza Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemagglutination inhibition (HI) antibody titres
Measured: October 2016 - August 2017
Secondary outcomes (4)
Pseudotype-based neutralization antibody titres
Measured: October 2016 - August 2017
Serum and saliva concentrations of total (and sub-classes of) IgA, IgG and IgM
Measured: October 2016 - August 2017
Concentrations of inflammatory mediators in RNA extracted from unstimulated and in vitro stimulated peripheral blood mononuclear cells.
Measured: October 2016 - August 2017
Plasma concentrations of markers of B and T cell activation
Measured: October 2016 - August 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kent, NHS Lincolnshire West Clinical Commissioning Group, NHS South Lincolnshire Clinical Commissioning Group
- Responsible party
- Principal investigator, Arwel Jones, University of Lincoln
- Investigators
- Glen Davison, PhD, Principal investigator, University of Kent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900209
- Sponsor's protocol ID
- CoSREC192
- Status last verified
- Oct 2017
- First submitted
- 9 Sep 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responses of the Immune System to Influenza Vaccination in Phenotypes of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02900209
- Acronym / sponsor ID
- CoSREC192
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Influenza, Exacerbations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Collaborators
- University of Kent, NHS Lincolnshire West Clinical Commissioning Group, NHS South Lincolnshire Clinical Commissioning Group
- Study start
- Oct 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 Sep 2016 (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.
The aim of this study is to determine responses of the immune system to the annual flu vaccination in people with COPD who experience frequent or infrequent exacerbations and healthy participants. We will collect blood and saliva immediately before and one month after flu vaccination at GP surgeries in the Autumn/Winter period. By measuring how quickly antibodies (that provide protection against infection) develop in the blood after vaccination we can provide important new information to help confirm whether those prone to COPD flare ups have weaker immune systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD frequent exacerbators | – | Other: Influenza VaccinationAged 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. |
| COPD infrequent exacerbators | – | Other: Influenza VaccinationAged 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. |
| Healthy controls | – | Other: Influenza VaccinationAged 65-85 years and do not have any symptoms of lung disease and have normal spirometry. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients 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) and moderate to severe airflow limitation (FEV1 30-80% predicted) will be approached. We will also include healthy participants as a control reference group who are aged 65-85 years without symptoms of lung disease and have normal spirometry.
Key inclusion criteria (2 listed)
- Patients 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) and moderate to severe airflow limitation (FEV1 30-80% predicted) who opt to receive the annual influenza vaccine.
- We will also include healthy participants aged 65-85 years without symptoms of lung disease who opt to receive the annual influenza vaccine.
Key exclusion criteria (17 listed)
- Unable/unwilling to provide informed consent
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza Vaccination | Other | COPD frequent exacerbators, COPD infrequent exacerbators, Healthy controls |
Primary outcome
Haemagglutination inhibition (HI) antibody titres
Time frame: October 2016 - August 2017
4 secondary outcomes
Pseudotype-based neutralization antibody titres
Time frame: October 2016 - August 2017
Serum and saliva concentrations of total (and sub-classes of) IgA, IgG and IgM
Time frame: October 2016 - August 2017
Concentrations of inflammatory mediators in RNA extracted from unstimulated and in vitro stimulated peripheral blood mononuclear cells.
Time frame: October 2016 - August 2017
Plasma concentrations of markers of B and T cell activation
Time frame: October 2016 - August 2017
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 26 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Disease, Chronic Obstructive
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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.
Glen Davison, PhD principal investigator
University of Kent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Lincoln at 2 sites 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 2 inclusion and 17 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Haemagglutination inhibition (HI) antibody titres (time frame: October 2016 - August 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2017; AzTrials last refreshed its copy on 31 Oct 2026.