Unwanted effects of corticosteroids in children with airway disease
Research type
Research Study
Full title
Unwanted effects of inhaled corticosteroids in children with airway diseases
IRAS ID
227592
Contact name
Louise Fleming
Contact email
Sponsor organisation
Imperial College, London
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
Inhaled corticosteroids (ICS) are an important treatment for inflammatory airways disease but can have side effects. Side effects occur because some of the inhaled drug is absorbed into the blood stream. We want to understand why some children experience these side effects (and some do not) and how we can identify them.
Adrenal glands make a hormone called cortisol which controls blood sugar levels and breaks down body fat and muscle. When children are prescribed high doses of inhaled steroids, the body’s natural production of cortisol is suppressed. If the adrenal glands are unable to increase production during times of stress/illness this can cause problems such as tiredness and low blood sugar. There have been deaths caused by adrenal insufficiency in children prescribed high doses of ICS.
There are a number of reasons why some children prescribed high doses of steroids experience side effects which we will investigate as part of this study:
1. They have varying degrees of inflamed (swollen) airways. This study will investigate whether there is less absorption of steroid into the blood stream (and hence less adrenal suppression) if airways are very swollen and inflamed.
2. We will monitor adherence to inhaled steroids and assess if there is any difference in adrenal suppression at the end of the monitoring period.
3. We will include children with different types of inflammatory airways diseases prescribed high doses of ICS: asthma and chronic suppurative lung disease (cystic fibrosis and primary ciliary dyskinesia) to see whether the underlying disease and pattern of inflammation play a role in adrenal suppression.
This study will test urine and saliva to see if we can identify children at risk of steroid side effects. Blood will be taken and stored for future genetic analysis of ability to metabolise steroids. Urine will be stored to look for steroid metabolites (metabolomics).REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/2084
Date of REC Opinion
12 Feb 2018
REC opinion
Further Information Favourable Opinion