Phase 4
Completed N=31
The Role of Montelukast in Rhinitis and Sleep
Perennial Allergic Rhinitis
Source: ClinicalTrials.gov NCT00590772 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks — -0.64; 0.13; 0.46; -0.25 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks |
-0.64; 0.13; 0.46; -0.25; 0.43; -0.32 | — |
Eligibility Criteria
Inclusion Criteria
Inclusion criteria will include:
- Age 16 to 65.
- History of allergic rhinitis.
- The ability to be placed on placebo without significant compromise in the quality of life.
- General good health.
- Ability to comply with the protocol and sign an informed consent.
- Have daytime sleepiness by history.
- Have poor sleep by history.
- Have fatigue by history.
- Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite) with correlating symptoms.
Exclusion Criteria
- Age fewer than 16 or over 65 years.
- A history of sleep apnea.
- Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma.
- Non-allergic rhinitis.
- Obesity.
- Inability to tolerate montelukast.
- Significant other diseases as determined by the investigator.
- Use of a research medication within 30 days.
- Use of a nasal steroid or topical antihistamine or decongestant within 30 days.
- Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or H2-blockers.
- Excessive use of alcohol or drug abuse.
- Inability to stop medication use during run-in period.
- Use of an oral antihistamine within 1 week of enrollment.
- Failed to have benefit when montelukast was used for rhinitis or asthma in the past
Data sourced from ClinicalTrials.gov (NCT00590772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.