The Role of Montelukast in Rhinitis and Sleep
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease
      nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep
      fragmentation in individuals with year round allergic rhinitis or perennial allergic rhinitis
      (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.
    

Detailed description: 
      Montelukast is a once daily LRA indicated for the treatment of allergic rhinitis and asthma,
      which is both safe and effective. Documented improvement in nasal congestion has been showed
      in patients with both seasonal and perennial allergic rhinitis. As demonstrated in recent
      publications, we fully anticipate that nasal congestion will be reduced in individuals
      afflicted with AR treated with montelukast. We have previously documented that a decrease in
      nasal congestion is associated with improved subjective sleep quality and subjective
      improvement in daytime somnolence. However, we have not demonstrated a cause and effect
      relationship. Currently, we have a study being performed that will allow us to assess the
      effect of nasal steroids on objective sleep by collecting data using a traditional overnight
      sleep test in subjects with congestion. We have not yet determined if subjective instruments
      for daytime somnolence correlate with objective measurements of improved daytime sleepiness.
      The purpose of this protocol will be three fold. First, we hope to determine the
      effectiveness of montelukast to reduce fatigue, somnolence and improve sleep, by reducing
      nasal congestion in allergic rhinitis. Two, we will assess the statistical relation between
      subjective instruments for sleepiness. Lastly, we want to determine the most appropriate test
      to use to determine daytime sleepiness or somnolence in patients with seasonal allergen
      induced congestion and daytime sleepiness.

      We will be dosing montelukast once a day, which is the manufacturer's suggested dosing
      schedule. Active drug will be compared to a placebo vehicle, which will mimic the active
      drug. With the proposed design study, a run-in period is not essential; however, to establish
      baseline symptoms and adherence to therapy, we have chosen a 1-week run-in while on placebo.
      After run-in, patients will be randomized to either active drug or placebo after baseline
      questionnaires and other data are collected. A daily diary to determine symptoms of allergic
      rhinitis and nighttime disturbance, as well as, daytime fatigue will be issued and expected
      to be completed daily. Two weeks after randomization, a follow-up will be scheduled in order
      to insure compliance, to collect diaries, administer questionnaires, and start the second
      treatment phase. After this visit study subjects will enter a 1-week wash-out and have a
      return visit before being randomized to the alternative arm. At six weeks, subjects will
      again be seen to insure compliance and administer questionnaires. The study will conclude
      following six-weeks. The data used for analyses will be the data collected during the last
      week of each randomized period. This will decrease cross over affect, typically seen in
      classical cross over studies, since there will be only a short washout between cross over.

      Subjects selected for this study will have a history of allergic rhinitis and a positive RAST
      or skin test to a perennial (year round) allergen and have symptoms that correlate with this
      allergen. If prior skin test or RAST is not available, a skin test will be performed to
      confirm allergic rhinitis. The patients will be seen in either the Allergy, Asthma, and
      Respiratory research center or the GCRC. All care and all studies will be done free of charge
      at no cost to the subject. Each subject will be compensated for his or her participation as
      outlined below.

      Patients will also be expected to have fatigue, daytime somnolence and poor sleep on study
      entry. An instrument to access the degree of fatigue, sleepiness and sleep quality will not
      only be required to be positive, but also must designate the symptom as greater than 50% on a
      severity rating.
    

Intervention name(s): montelukast; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg po each day (compared to placebo for 2 weeks); placebo for 2 weeks
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep; somnolence; allergies; rhinitis; fatigue