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The Effect of Pseudoephedrine on Rhinitis and Sleep

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ClinicalTrials.gov Identifier: NCT00704496
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Timothy Craig, Milton S. Hershey Medical Center

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 sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.

Condition or disease Intervention/treatment Phase
Rhinitis Sleep Drug: Pseudoephedrine Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Pseudoephedrine on Rhinitis and Sleep
Study Start Date : June 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day
Other Name: Placebo

Active Comparator: Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day
Drug: Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day
Other Name: Placebo




Primary Outcome Measures :
  1. Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo [ Time Frame: 3 years ]
    sleep improvement by subjective questionnaires


Secondary Outcome Measures :
  1. Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo [ Time Frame: 3 years ]
    daytime sleepiness by subjective questionnaires



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 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 18 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. Hypertension
  6. Diabetes Mellitus
  7. Inability to tolerate pseudoephedrine
  8. Significant other diseases as determined by the investigator.
  9. Use of a research medication within 30 days.
  10. Use of a nasal steroid or topical antihistamine or decongestant within 30 days.
  11. Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or H2-blockers.
  12. Excessive use of alcohol or drug abuse.
  13. Inability to stop medication use during run-in period.
  14. Use of an oral antihistamine within 1 week of enrollment.
  15. Failed to have benefit when pseudoephedrine was used for rhinitis or asthma in the past

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704496


Locations
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United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Timothy J Craig, D.O. Penn State University

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Responsible Party: Timothy Craig, Timothy Craig, D.O., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00704496     History of Changes
Other Study ID Numbers: 25325
First Posted: June 25, 2008    Key Record Dates
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Timothy Craig, Milton S. Hershey Medical Center:
Sleep, Pseudoephedrine
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pseudoephedrine
Ephedrine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action