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.