Inhaled Interferon Beta-1a vs placebo in asthma patients
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel group, multi-centre Phase IIa study in asthma patients comparing the efficacy and safety of once daily inhaled Interferon beta-1a to placebo, administered for 14 days after the onset of symptoms of an upper respiratory tract infection for the prevention of severe exacerbations
IRAS ID
177204
Contact name
Per Gustafson
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-005084-32
Research summary
The majority of asthma exacerbations, especially in more severe disease, are caused by respiratory viruses, e.g. the viruses causing the common cold and the flu. There is currently no antiviral treatment shown to prevent asthma exacerbations triggered by infections in the respiratory tract, and it can be hypothesised that an antiviral treatment that might prevent or attenuate exacerbations could provide a major breakthrough preventing morbidity in patients with severe asthma. Interferon is produced in the body upon viral infections, and helps to coordinate the body’s immune response and limit the spread and impact of infection. In asthma patients the interferon response to viral triggers appears to be reduced, leading to increased risk of asthma exacerbation.
This study is designed to investigate if inhaled Interferon beta-1a, on top of background asthma standard of care, prevents or attenuates severe exacerbation when the treatment is initiated after onset of symptoms of cold or the flu.
The patients will be screened and entered into a pre-treatment phase where they remain until they develop cold or flu symptoms. Upon symptoms the patients are assessed and entered into the treatment phase of the study where treatment needs to be initiated within 48 hours of symptom onset. The treatment consists of a once daily inhalation for 14 days. Patients will be followed during the treatment phase and for 2 weeks after the last dose of medication.
The study is planned to take place in approximately 35 centres in 5 countries. Approximately 400 patients with moderate to severe asthma will be recruited into the study in order to achieve approximately 220 patients randomised in a 1:1 ratio to study drug or placebo
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0256
Date of REC Opinion
5 Jun 2015
REC opinion
Further Information Favourable Opinion