The goal of this study is to examine exacerbations of chronic obstructive pulmonary disease (COPD) caused by a common cold virus called rhinovirus, to identify new treatments. Exacerbations are flare-ups of respiratory symptoms which are a major cause of ill health in people with COPD, and are most commonly caused by viruses.
The main questions the study aims to answer are:
* What processes in the body occur in response to rhinovirus infection, and do the differences between people with COPD and healthy volunteers explain why people with COPD develop more severe illness and exacerbations? * Can treatments be identified that target these processes to reduce the severity and frequency of exacerbations in people with COPD?
The study will compare eligible participants with COPD to healthy volunteers, and will involve intentionally infecting each participant with rhinovirus in a controlled environment. They will undergo baseline investigations prior to infection including a first bronchoscopy. Post-infection each participant will undergo a range of tests, including a second bronchoscopy, to compare how processes in the body, and especially the lungs, differ between people who do and do not have COPD.
Male or female sex
Age ≥40 years and ≤75 years at the time of signing the consent form
Medical history or clinical diagnosis of COPD
Cumulative smoking history of at least 20 pack years
Bronchiectasis including cystic fibrosis
Bronchiolitis obliterans
Carcinoma of the bronchus
Fibrosis such as tuberculosis (TB), idiopathic pulmonary fibrosis
This study will recruit participants that respond to advertisement or invitations to participate in the study, that meet the eligibility criteria, and whom are willing and able to consent to take part in this study which involves 15 study visits over the course of 7-10 weeks.
Case-control
Prospective
Rhinovirus-A16
Biological/VaccineNasal inoculation with a dose equivalent to 100 TCID50 of rhinovirus-A16 inoculum will be administered to all participants in the study
Lower Respiratory Symptom Score (LRSS)
Participants will be asked to record their lower respiratory tract symptom scores daily prior to and in the 42 days following viral infection with rhinovirus A-16. Participants will rate their shortness of breath, wheeze, cough, sputum quality and quantity. Total score ranges from 0-17, with higher scores indicating more severe symptoms.
Upper Respiratory Symptom Score (URSS)
Participants will be asked to record their upper respiratory tract symptom scores daily prior to and in the 42 days following viral infection with rhinovirus A-16. Participants will rate their symptoms of cough, sneezing, runny nose, blocked nose, headache, sore throat, malaise, and fever. Total score ranges from 0-24, with higher scores indicating more severe symptoms.
EXAcerbations of Chronic pulmonary disease Tool-Patient Reported Outcomes (EXACT-PRO)
Participants will be asked to record scores for symptoms commonly experienced in COPD exacerbations daily prior to and in the 42 days following viral infection with rhinovirus A-16. Participants will rate their chest congestion, cough, mucus quality and quantity, chest discomfort, chest tightness, general breathlessness, shortness of breath whilst performing personal care, indoor activities and outside errands, tiredness, sleep, and anxiety. Total score ranges from 0-100, with higher scores indicating more severe symptoms.
Forced Expiratory Volume in 1 second (FEV1)
Investigators will perform lung function/spirometry at baseline, immediately prior to inoculation, and at every clinical visit after RV inoculation. The primary measure of lung function will be the forced expiratory volume in 1 second (FEV1), which is a measure of larger airway patency and is impaired in COPD and further impaired in exacerbations of COPD.
Airway Oscillometry
Airway oscillometry is a technique used to measure airflow and patency of the airways, and is a more sensitive measure of small airway dysfunction than spirometry and FEV1.
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Imperial College London
Lead sponsor
Imperial College Healthcare NHS Trust
Collaborator
