A Study in Asthma Patients to Evaluate Efficacy, Safety and Tolerability of 14 Days Once Daily Inhaled Interferon Beta-1a After the Onset of Symptoms of an Upper Respiratory Tract Infection
Condition: Asthma
MeSH terms: Infections; Respiratory Tract Infections; Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent
      or reduce the severity of asthma attacks when administered to asthma patients at the onset of
      symptoms of common cold or influenza
    

Detailed description: 
      The study will consist of a Pre-Treatment Phase followed by a Treatment Phase. Patients are
      screened and enter the Pre-Treatment phase where they remain until they develop symptoms of a
      common cold or the flu. During this Pre-Treatment Phase patients will be asked daily if they
      think they have a common cold or the flu. When the patient answers yes to the question that
      he/she is coming down with a common cold or the flu, arrangements are made to evaluate the
      patient at the study site and, if eligible, enters the Treatment Phase. Baseline assessments
      are performed and the patient is randomized 1:1 to receive 24 μg (metered dose) inhaled
      Interferon beta-1a or placebo once daily for 14 days (delivered by the I-neb® device [Philips
      Respironics]). Treatment should start as soon as possible but no later than 48 hours after
      the onset of the first of the common cold or flu symptoms. Patients will be assessed with
      regards to exacerbations and changes in respiratory symptoms and reliever medication use at
      home using an ePRO device. Lung function will be measured both at home by the patients and at
      the study site. There will be five clinical visits during the Treatment Phase and two visits
      after the end of treatment; efficacy and safety will be monitored until 2-3 weeks after end
      of treatment when a final follow-up visit will take place.

      The study population will comprise adult asthmatic patients on a maintenance treatment of
      medium to high dose inhaled corticosteroids and a second controller medication (eg, long-
      acting β2 agonist), with a documented history of at least two severe exacerbations within the
      last 24 months, of which at least one has occurred during the last 12 months, and it is
      suspected by the patient that these aforementioned exacerbations were triggered by an upper
      respiratory tract infection (ie, related to symptoms of a common cold or the flu).
    

Intervention name(s): Interferon beta-1a Nebuliser solution 48 μg/mL; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Interferon beta-1a, 0,5 ml (24 μg, metered dose) once daily inhalation for 14 days; Placebo solution for once daily inhalation for 14 days
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: asthma; Upper Respiratory Tract Infection; exacerbation; Interferon; efficacy; safety; prevention