Plain English Summary
Background and study aims
Cystic fibrosis (CF) is a genetic disease which affects the whole body, but respiratory/lung disease is the most prominent problem. Patients with CF are colonised by different bacteria and fungi which can cause lung disease of varying severity, and one of these bugs is the fungus Aspergillus. Aspergillus is a fungus that is found in the environment, and while people with normal lungs and immune system are not affected by the fungus, CF patient's lungs are particularly vulnerable to infection. There are four potential types of Aspergillus disease in CF which have been recently described in a previous study and the health consequences of these types of disease are not well known in comparison to each other. The aim of this study is to look back at the patients involved in the original study that proposed the four types of Aspergillus disease and investigate the decline in health and survival outcomes for each type. Patients may change disease type over time, therefore patients from the previous study are re-tested and re-diagnosed as an Aspergillus disease type to investigate this. As Aspergillus is found in the environment the levels of Aspergillus found in the air both in the CF unit and in patient's homes are measured using environmental sampling to understand more about the risks of acquiring Aspergillus lung disease, and the effects of ventilation in potentially reducing environmental levels.
Who can participate?
Cystic fibrosis patients aged over 18 who were involved in the previous study to classify Aspergillus disease are approached to be involved in this study
What does the study involve?
Participants have a blood sample and a sputum sample taken to re-test for Aspergillus disease type. These tests are done as part of a CF patient's normal care and do not require an extra trip to the hospital. Patients are also given the option to have their home air tested for the presence of Aspergillus, and this is done by the doctor at a home visit of less than 30 minutes.
What are the possible benefits and risks of participating?
The benefit of taking part in this study is to help increase knowledge of Aspergillus disease in CF. No risks are foreseen.
Where is the study run from?
The Manchester Adult Cystic Fibrosis Centre in Wythenshawe Hospital in Manchester (UK)
When is the study starting and how long is it expected to run for?
September 2016 to September 2018
Who is funding the study?
Manchester Adult Cystic Fibrosis Centre (UK)
Who is the main contact?
Dr Lisa Collier
lisa.collier@mft.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lisa Collier
ORCID ID
Contact details
Manchester Adult Cystic Fibrosis Centre
Manchester University NHS Foundation Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 4321
lisa.collier@mft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRAS232722
Study information
Scientific title
Clinical consequences of Aspergillus colonisation and disease in cystic fibrosis and the role of environment in acquisition and infection
Acronym
AspCF
Study hypothesis
Aspergillus disease in cystic fibrosis can be classified into four phenotypes (1. No disease, 2. Allergic bronchopulmonary aspergillosis, 3. Aspergillus sensitised, 4. Aspergillus bronchitis). The diagnostic criteria for these classifications was outlined by Baxter et al. 2013 and the same patient cohort used in this study will be followed up to 9 years to review clinical consequences of each class of disease, survival outcomes, and be prospectively re-classified to ascertain whether patient change disease class over time.
Ethics approval
North West - Liverpool East - submission pending
Study design
Single-centre longitudinal cohort study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Pulmonary Aspergillus disease in patients with cystic fibrosis
Intervention
Patients involved in the previous trial which classified aspergillus disease by phenotype (REC ref: 07/Q1403/70) will followed up to the current day to monitor clinical outcomes and clinical decline, in order to compare the severity of each phenotype. The surviving patients will be approached to consent to reclassification of Aspergillus disease by means of blood test for Aspergillus IgE, Aspergillus IgG, Total IgE and Galactomannan, along with a sputum sample for Aspergillus. These tests form regular follow up of these patients and will not require hospital appointments above their usual outpatient follow up. They will also be asked if they will consent to environmental air sampling of their home either by drop plates being sent to them and/or microbial air sampling. Patients can choose to consent to either or both re-classification and environmental sampling.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Diagnosis of Aspergillus phenotype by means of blood test for Aspergillus IgE, Aspergillus IgG, Total IgE and Galactomannan, along with a sputum sample for Aspergillus, both at baseline . This is compared to previous phenotype diagnosed in study REC ref: 07/Q1403/70 to establish if change in disease class has occurred
2. Comparison of survival outcomes between class 1-4 of Aspergillus disease (present day snapshot of the patient population), and rate of clinical decline (marked by FEV1 % predicted and BMI measurements taken yearly)
Secondary outcome measures
Aspergillus/fungal exposure at a patient's residence, determined by environmental sampling at baseline. This will supplement data collected as part of air quality surveys undertaken in the cystic fibrosis unit, both in inpatient and outpatient areas
Overall trial start date
30/09/2016
Overall trial end date
30/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients will have taken part in study REC ref: 07/Q1403/70 between 2008-2011 (number = 129). Surviving patients who have not received a lung transplant or moved away from the unit since that time will be eligible for prospective reclassification of Aspergillus disease. All 129 patients will be followed up for retrospective data.
1. Cystic fibrosis patients > 18 years old, both male and female
2. Patients who have taken part in study REC ref: 07/Q1403/70
3. Patients eligible for reclassification of Aspergillus disease if not undergone lung transplantation or not moved away from area
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
129 patients eligible for retrospective review. 84 patients eligible for reclassification of disease and environmental home sampling. The aim is to reclassify 70 patients and do environmental sampling with up to 40 patients
Participant exclusion criteria
1. Non cystic fibrosis patients
2. Patients not involved in study REC reference number 07/Q1403/70
3. Patients who have undergone lung transplantation
4. Patients who have moved away from the area during follow-up time from original study
Recruitment start date
01/01/2018
Recruitment end date
30/09/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wythenshawe Hospital
Manchester University NHS Foundation Trust
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Manchester Adult Cystic Fibrosis Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
There is a study protocol and patient information sheet that will be available, it is not currently online. Results will be written up as part of an MD thesis. The results of both the clinical outcomes of Aspergillus disease in CF and the potential change in classification of Aspergillus disease overtime, as well as the Aspergillus environmental sampling in hospital and patient homes are planned to be submitted for publication at the end of 2018. The results of the study will also be shared with the participating patients. Interim data and results will be submitted to international conferences for both poster and presentations.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Andrew Jones.
Intention to publish date
31/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list