The Role of Montelukast in Rhinitis and Sleep

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.