The PK ,safety & tolerability of Fevipiprant in Children aged 6 to <12
Research type
Research Study
Full title
A multicenter, open-label, 8 day treatment study to assess the pharmacokinetics, safety and tolerability of fevipiprant delivered via a once daily chewable tablet in children aged 6 to <12 years with asthma
IRAS ID
264789
Contact name
Atul Gupta
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-003920-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 23 days
Research summary
Asthma affects over 300 million people worldwide, 8 million+ of which are in the UK (~12% of the UK population)..Asthma accounts 60,000 hospital admissions, and 200,000 bed days per year in the UK.
Asthma prevalence is considerably higher in children compared to adults and it is the most common chronic condition in children. The UK has one of the highest childhood asthma rates in the world (ISAAC study) with approximately 1.1 million children, the equivalent of 1 in 12 children, diagnosed with the condition. Asthma has a considerable impact on a child’s quality of life, affecting, daily activity, school absenteeism, A&E attendance and hospitalisation - 11.6% of UK children aged 6 to 7 years have asthma.
Despite the majority of school-aged children (>95%) with asthma have mild to moderate disease which can be controlled with relatively low and safe doses of maintenance inhaled corticosteroids (ICS), a minority have persistent poor control and/or frequent asthma attacks despite maximal prescribed maintenance therapy. This group, with problematic severe asthma are a significant clinical challenge as they have marked morbidity utilise more than 50% of all healthcare resources for asthma and are at increased risk of asthma death. Improving control and reducing risk for children with problematic severe asthma is therefore an urgent unmet clinical need.
Novartis is developing fevipiprant, a selective, orally-administered, reversible, competitive antagonist, which works to suppress key inflammatory pathways in asthma thus expecting to reduce severe exacerbations, improving asthma control and quality in life. This in turn would help reduce patient hospitialisations. Although there is no published efficacy data of such antagonists children below the age of 12, fevipiprant has the potential to be of significant benefit over therapeutic alternatives based on clinical data to date in the adult population.
This study aims to assess the pharmacokinetics of fevipiprant (QAW039) delivered as a chewable tablet in paediatric asthma subjects aged 6 to < 12 years. The results of this study will support the identification of a fevipiprant dose for future paediatric efficacy studies aiming to provide an exposure similar to that of the to-be marketed adult/adolescent dose. In addition, the first data on safety and tolerability of fevipiprant in this age group will be obtained.
3 UK participants will be recruited across 3 sites and remain in the study for about 42 days , attending 3 visits and receiving 1 telephone call. Approximately 24 participants aged 6 to <12 years old are expected to complete the study globally.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0394
Date of REC Opinion
6 Aug 2019
REC opinion
Further Information Favourable Opinion