The Effect of Pseudoephedrine on Rhinitis and Sleep

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Penn State University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00704496
First received: June 24, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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 Intervention
Rhinitis
Sleep
Drug: Pseudoephedrine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Improvement of sleep associated with the use of pseudoephedrine as compared to the placebo [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of daytime somnolence with pseudoephedrine as compared to placebo [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: June 2007
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Active Comparator: Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day
Drug: Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704496

Contacts
Contact: Timothy J Craig, D.O. 717-531-6525 tcraig@psu.edu

Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Timothy J Craig, D.O.    717-531-6525    tcraig@psu.edu   
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Timothy J Craig, D.O. Penn State University
  More Information

No publications provided

Responsible Party: Timothy Craig, D.O., Penn State University
ClinicalTrials.gov Identifier: NCT00704496     History of Changes
Other Study ID Numbers: 25325, 25325
Study First Received: June 24, 2008
Last Updated: June 24, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Sleep, Pseudoephedrine

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pseudoephedrine
Ephedrine
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014