Be Part of Research - Trial Details - Biomarkers in respiratory immunology

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Open to: All Genders

Age: Adult

Medical Conditions

Respiratory infection and inflammation

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This study primarily focuses on a type of bacteria called pneumococcus. This bacteria is the most common cause of pneumonia. In this study, bronchoscopic (camera tests into the lungs) data will be collected from participants with healthy lungs and also those with respiratory diseases. Bronchoscopy is a useful and well-tolerated research method. When studying respiratory diseases obtaining lung/lower respiratory tract cells, rather than just blood cells, is increasingly accepted as best research practice.
When performing bronchoscopy, fluid can be instilled into the lungs and withdrawn with manual hand-held suction – this is called research bronchoalveolar lavage (BAL). This enables the removal of lung cells and lung lining fluid from the lung mucosal surface. BAL has assumed a more prominent role in diagnosis and management of lung disease, and hopefully in the future as a prognostic tool.
This study aims to use research bronchoscopy and BAL to collect immune and clinical data for the exploration of different respiratory biomarkers (indicators of disease) that correlate with lung infection and protection, and the impact of ageing on the immune system in the lungs.

Participants will undergo several upper respiratory tract investigations:
1. Nasosorption, where a small piece of blotting paper is placed inside the nostril and held there for up to 3 minutes
2. Nasal wash, where a little salty water is gently squirted into the nose and the water is collected as it runs out
3. Nasal swab - a cotton swab is inserted gently into the nose
4. Nasal cells, collected from the inner surface of the nostril using a very thin plastic spoon
5. Throat swab - a small cotton swab is used to wipe the back of the throat
All participants will undergo a bronchoscopy as a day procedure at the hospital, with local anaesthetic and if required, sedation. The preparation time will take around 15-20 minute and the procedure itself will take around 7-15 minutes. Participants will be observed for at least 2 hours following bronchoscopy. During this procedure, blotting paper will be passed down the bronchoscope, similarly to the nasosorption procedure. Bronchoalveolar lavage (BAL) will also be performed as part of the bronchoscopy. Saline solution (around the same amount as a cup of tea) will be introduced to the lung and then withdrawn using gentle suction. Bronchial brushing involves a small brush being passed down the bronchoscope to obtain a cell sample from the lung lining.
All participants will have blood samples taken at their screening/consent visit and at their bronchoscopy visit.
All participants will be asked to telephone the research team the day after the bronchoscopy to inform them of any problems, provide feedback and check participants are feeling well.
Occasionally participants will be invited for a clinical follow up with the research team. This will involve a clinical exam, asking a few questions about symptoms and monitoring vital signs (heart rate, blood pressure and temperature)

1. Healthy adult males and non-pregnant females
2. Adults with respiratory disease, including asthma, COPD, pulmonary fibrosis, bronchiestasis, recent pneumonia or lower respiratory tract infection

You can take part if:

You may not be able to take part if:

Any of the following will exclude participants from the study:1. Uncontrolled medical or surgical conditions that may preclude nasal or oral intubation with a bronchoscope or the bronchoscopy itself, in the opinion of the investigator2. Any report of acute illness or febrile event that has not resolved 72 hours before bronchoscopy3. Previous adverse reactions to benzodiazepines or anaesthetic agents (lidocaine) including reversal agents such as flumazenil4. Participated (taken investigative drug and/or device) in another clinical trial within 1 month or within drug’s 5 half-lives, whichever is longer, before the study procedure (this is not relevant to participants in an EHPC study)5. Full blood count, clotting or renal function level outside of normal range and deemed as clinically significant by the investigator6. Very poor venous access7. Not abstained from alcoholic beverages or alcohol-containing products for at least 24 hours before bronchoscopy8. Receipt of blood products within 2 months prior to screening 9. Should not participate in this study for their own safety in the opinion of the Investigator (or designee)

Exclusion criteria for participants with acute or chronic respiratory disease such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, bronchiectasis, pneumonia or lower respiratory tract infection:1. Unable to perform spirometry (spirometry must be within 6 months prior to screening)2. On long term oxygen therapy (LTOT)3. Oxygen saturations on screening of <92% on air4. Any uncontrolled medical or surgical condition as deemed clinically significant by the CI

Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
Liverpool University Hospitals NHS Foundation Trust
Royal Liverpool University Hospital Prescot Street
Liverpool
L7 8XP
Accelerator Research Clinic (ARC)
Liverpool Life Sciences Accelerator 1 Daulby Street
Liverpool
L7 8XZ
RLBUH
Clinical Research Unit Prescott Street
Liverpool
L7 8XP

There is no immediate benefit to the participants; however, they will be reimbursed for their time and involvement.
The risks associated with blood sampling and cannulation are minimal, but this may cause temporary pain, bruising and/or bleeding to the arm. Blood sampling and cannula insertion will be performed by trained medical professionals.
Bronchoscopy is classed as a safe procedure, which carries little risk. Most people do not suffer any ill effects but of those that do, the common side effects are a sore throat and hoarseness for a few hours, or perhaps nasal discomfort and a cough after. Therefore, all participants are observed for at least two hours after bronchoscopy. It is possible that participants will experience a drop-in blood oxygen levels or breathlessness during the procedure and if these occur, the procedure may be stopped. Up to 25% of people experience mild right sided chest pain with mild fever) for some hours during the evening/night, following the procedure. Major complications would include breathing difficulties (from sedative medication or temporary blockage of the airway), abnormal heart rhythm and infection.
The risks associated with bronchial brushing and bronchosorption are minimal. Bronchial brushing can cause minor bleeding. During bronchosorption, the blotting paper could dislodge from the wire/catheter, this would be retrieved using biopsy forceps at the time of the bronchoscopy or may be spontaneously coughed up after the bronchoscopy itself. This risk is reduced by screening participants and checking clinical bloods prior to the procedure and with the bronchoscopy being performed by a highly trained specialist team.
There is limited risk associated with taking upper respiratory samples. During a nasal wash, participants may swallow a small amount of salty water however this is harmless. The throat swab may make you gag a little. The nasal swab can be a little uncomfortable (this passes very quickly) and may cause a small amount of bleeding, but this is uncommon. The nasosorption can tickle the nose a little. The nasal cell sample is slightly uncomfortable and may make your eyes water, this is very momentary. Sometimes a small amount of blood can be evident on the sample probe; however, it is highly unusual for it to cause an actual nose bleed.

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Read full details for Trial ID: ISRCTN45524058

Or CPMS 39473

Last updated 25 September 2024

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Biomarkers in respiratory immunology

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Age: Adult

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