The Role of Montelukast in Rhinitis and Sleep

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penn State University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

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