AIRSPACE
Research type
Research Study
Full title
Assessing the Inflammatory and Microbial Response to Intravenous Antibiotics in Cystic Fibrosis Pulmonary Exacerbations (AIRSPACE)
IRAS ID
259574
Contact name
Damian Downey
Contact email
Sponsor organisation
Queen's University Belfast
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Cystic fibrosis (CF) is a genetic disorder affecting multiple organs. Lung damage caused by persistent infection and inflammation is the greatest contributor to the disease burden. People with CF (PWCF) experience periods of acute infection, termed pulmonary exacerbations, where chest symptoms worsen and hospital admission for treatment with intravenous (IV) antibiotics is required. This impacts on their quality of life. Lung function often decreases during an exacerbation and at least a quarter of PWCF will not recover their normal lung function after treatment. This increases their risk of an exacerbation occurring again shortly after. We want to understand why some people with CF don’t respond as well to IV antibiotic treatment and need several treatment courses.
This observational study aims to identify whether measurements taken during and following IV antibiotic treatment for a pulmonary exacerbation, vary between two cohorts of PWCF. Cohort 1: PWCF who have a previous history of frequent exacerbations. Cohort 2: PWCF who have a previous history of infrequent exacerbations.
The study will be undertaken at the Belfast Regional Adult CF Centre. Any adult with CF being admitted for intravenous treatment of a Pulmonary Exacerbation not enrolled in another randomised trial is eligible. Measurements will be taken on admission, day 3-5, end of treatment and 4-6 weeks post-treatment. It has been designed to coincide with routine patient care as much as possible.
A multi-dimensional assessment of the patient’s response to treatment will be obtained using routine parameters and additional parameters. Assessments will include clinical (vital signs and lung function), inflammatory (CRP and other biomarkers),and microbial (culture and non-culture based) measures. Clinical samples (blood and sputum) will be used to identify any differences in response.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/0811
Date of REC Opinion
8 May 2019
REC opinion
Favourable Opinion