Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      People with asthma may have asthma worsening when they have an upper respiratory infection
      due to a virus or a common cold. Leukotrienes are increased in nasal secretions from children
      with Respiratory Syncytial Virus (RSV) and lung washings during times of acute lung
      inflammation. Experimental virus exposure in adults is also associated with increases in
      nasal leukotrienes.

      The degree to which leukotrienes play a role in asthma worsening is unknown.There is
      information linking leukotrienes to viral infections, allergic inflammation, and asthma
      exacerbation.This information supports the hypothesis that virus-induced leukotrienes
      contribute to the severity of respiratory infections and in susceptible individuals, lead to
      lower airway obstruction and exacerbations of asthma. We propose to use montelukast in an
      experimental viral challenge model to explore this hypothesis.
    

Detailed description: 
      Viral infections are important causes of wheezing illnesses throughout childhood and in
      adults with asthma. There has been progress in identifying mechanisms and risk factors for
      severe respiratory symptoms, and in particular, wheezing. Given this close relationship, it
      would be attractive to apply antiviral strategies to the prevention and treatment of asthma,
      and both RV and RSV are obvious targets. Unfortunately, attempts at developing an RSV vaccine
      have so far been unsuccessful, and vaccination to prevent RV infection does not seem to be
      feasible due to the large number of serotypes. Antiviral medications have been tested in
      clinical trials, however one problem with this approach is that once the clinical signs and
      symptoms appear, viral replication is well underway.

      The other potential therapeutic approach for respiratory viral infections would be to
      selectively inhibit pro-inflammatory immune responses induced by the virus. The beneficial
      effects of systemic glucocorticoids indicate that this approach is valid; the challenge will
      be to develop treatments with greater efficacy and a reduced potential for adverse effects.
      The large body of information linking cysteinyl leukotrienes to viral infections, allergic
      inflammation, and asthma exacerbations, strongly supports the hypothesis that virus-induced
      leukotrienes contribute to the severity of respiratory infections and in susceptible
      individuals, lead to lower airway obstruction and exacerbations of asthma. We propose to use
      montelukast in an experimental viral challenge model to explore this hypothesis.
    

Intervention name(s): montelukast; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg everyday; like placebo
Other intervention name(s): Singulair; like placebo
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: asthma; leukotrienes; rhinovirus