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:

Drug Information available for: Ephedrine Hydrochloride Pseudoephedrine Ephedrine sulfate Pseudoephedrine hydrochloride

U.S. FDA Resources

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 (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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


Responsible Party:	Timothy Craig, D.O., Penn State University
ClinicalTrials.gov Identifier:	NCT00704496 History of Changes
Other Study ID Numbers:	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 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

ClinicalTrials.gov processed this record on September 29, 2016

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