The Effect of Pseudoephedrine on Rhinitis and Sleep

Study Overview
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Brief Summary
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The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.

Detailed Description
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The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue. We studied patients treated with placebo compared to FDA approved dose of pseudoephedrine and assessed sleep, QOL and daytime sleepiness.

Official Title
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The Effect of Pseudoephedrine on Rhinitis and Sleep

Conditions
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Rhinitis, Sleep

Intervention / Treatment
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* Drug: Pseudoephedrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 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 18 or over 65 years. A history of sleep apnea. Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma. Non-allergic rhinitis. Hypertension Diabetes Mellitus Inability to tolerate pseudoephedrine 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 pseudoephedrine was used for rhinitis or asthma in the past

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Pseudoephedrine<br>* Pseudoephedrine is a 240 mg PO per day<br>* Other names: Placebo;|
| Active Comparator: Pseudoephedrine<br>Pseudoephedrine is a 240 mg PO per day | Drug: Pseudoephedrine<br>* Pseudoephedrine is a 240 mg PO per day<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo | sleep improvement by subjective questionnaires | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo | daytime sleepiness by subjective questionnaires | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Pseudoephedrine