The Role of Montelukast in Rhinitis and Sleep

Overview[ - collapse ][ - ]

Purpose 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.
ConditionPerennial Allergic Rhinitis
InterventionDrug: montelukast
Drug: placebo
PhasePhase 4
SponsorPenn State University
Responsible PartyPenn State University
ClinicalTrials.gov IdentifierNCT00590772
First ReceivedDecember 26, 2007
Last UpdatedFebruary 5, 2009
Last verifiedFebruary 2009

Tracking Information[ + expand ][ + ]

First Received DateDecember 26, 2007
Last Updated DateFebruary 5, 2009
Start DateMay 2003
Estimated Primary Completion DateJanuary 2009
Current Primary Outcome MeasuresThe primary outcome will be improvement of fatigue and daytime sleepiness [Time Frame: 2 weeks] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleThe Role of Montelukast in Rhinitis and Sleep
Official TitlePhase 4- The Role of Montelukast on Perennial Rhinitis and Associated Sleep Disturbance and Daytime Somnolence
Brief 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.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionPerennial Allergic Rhinitis
InterventionDrug: montelukast
10 mg po each day (compared to placebo for 2 weeks)
Other Names:
SingulairDrug: placebo
placebo for 2 weeks
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment50
Estimated Completion DateJanuary 2009
Estimated Primary Completion DateJanuary 2009
Eligibility Criteria
Inclusion Criteria:

Inclusion criteria will include:

1. Age 16 to 65.

2. History of allergic rhinitis.

3. The ability to be placed on placebo without significant compromise in the quality of
life.

4. General good health.

5. Ability to comply with the protocol and sign an informed consent.

6. Have daytime sleepiness by history.

7. Have poor sleep by history.

8. Have fatigue by history.

9. Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite)
with correlating symptoms.

Exclusion Criteria:

1. Age fewer than 16 or over 65 years.

2. A history of sleep apnea.

3. Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma.

4. Non-allergic rhinitis.

5. Obesity.

6. Inability to tolerate montelukast.

7. Significant other diseases as determined by the investigator.

8. Use of a research medication within 30 days.

9. Use of a nasal steroid or topical antihistamine or decongestant within 30 days.

10. Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or
H2-blockers.

11. Excessive use of alcohol or drug abuse.

12. Inability to stop medication use during run-in period.

13. Use of an oral antihistamine within 1 week of enrollment.

14. Failed to have benefit when montelukast was used for rhinitis or asthma in the past
GenderBoth
Ages16 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00590772
Other Study ID NumbersIRB 2003-114
Has Data Monitoring CommitteeNo
Information Provided ByPenn State University
Study SponsorPenn State University
CollaboratorsMerck Sharp & Dohme Corp.
Investigators Not Provided
Verification DateFebruary 2009