CFOR258D2416 - A study of an inhaled corticosteroid In pts with asthma
Research type
Research Study
Full title
A 26 week, randomized, active-controlled safety study of double-blind formoterol fumarate in free combination with an inhaled corticosteroid versus an inhaled corticosteroid in adolescent and adult patients with persistent asthma
IRAS ID
183494
Contact name
Ian Clifton
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-004854-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This is a clinical research study in people who are suffering from asthma. The purpose of this clinical research study is to test the safety of Foradil Aerolizer (formoterol) in people who are suffering from asthma. People with asthma are at risk for uncommon but serious problems such as hospitalisation, needing to have a tube put down their throat to help them breathe (intubation), or death due to asthma.
The question is whether participants taking inhaled corticosteroids, specifically fluticasone, in combination with formoterol have the same risk of having these serious problems as participants taking the inhaled corticosteroids (fluticasone) alone.
Foradil Aerolizer contains a medicine called formoterol, which is a long acting beta agonist (LABA). LABA are a type of bronchodilator medicine that relaxes (opens/dilates) the airways in the lungs to make breathing easier. Fluticasone is an inhaled corticosteroid, which helps reduce inflammation in the lungs to control asthma better.
We do not know if the addition of an inhaled corticosteroid, such as fluticasone, reduces the increased risk of asthma-related hospitalisations and death from formoterol. That is what this study is trying to find out.
Fluticasone is a type of medication used to treat asthma called inhaled corticosteroids. Inhaled corticosteroids are useful in treating asthma because they help treat and prevent inflammation (swelling) of the airways in people with asthma, making it easier to breathe. Formoterol is a medication that relaxes (opens/dilates) the airways to make breathing easier.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0325
Date of REC Opinion
15 Sep 2015
REC opinion
Further Information Favourable Opinion