The Effect of Pseudoephedrine on Rhinitis and Sleep - Full Text View

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	Phase
Rhinitis Sleep	Drug: Pseudoephedrine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Official Title:	The Effect of Pseudoephedrine on Rhinitis and Sleep

Resource links provided by NLM:

Drug Information available for: Pseudoephedrine

U.S. FDA Resources

Further study details as provided by Timothy Craig, Milton S. Hershey Medical Center:

Primary Outcome Measures:

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:

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


Enrollment:	34
Study Start Date:	June 2007
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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


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


Principal Investigator:	Timothy J Craig, D.O.	Penn State University

More Information


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 Submitted:	June 24, 2008
First Posted:	June 25, 2008
Results First Submitted:	September 20, 2017
Results First Posted:	October 18, 2017
Last Update Posted:	October 18, 2017
Last Verified:	September 2017


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:


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