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Status:

COMPLETED

The Effect of Pseudoephedrine on Rhinitis and Sleep

Lead Sponsor:

Milton S. Hershey Medical Center

Conditions:

Rhinitis

Sleep

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

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 sle...

Detailed Description

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 sle...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2009

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT00704496

Start Date

June 1 2007

End Date

September 1 2009

Last Update

October 18 2017

Active Locations (1)

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Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033