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Sponsored by: |
Penn State University |
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Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00704496 |
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 |
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Rhinitis Sleep |
Drug: Pseudoephedrine Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
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 |
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Placebo: Placebo Comparator
Placebo
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Drug: Placebo |
Pseudoephedrine: Active Comparator
Pseudoephedrine is a 240 mg PO per day
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Drug: Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Timothy J Craig, D.O. | 717-531-6525 | tcraig@psu.edu |
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 |
Principal Investigator: | Timothy J Craig, D.O. | Penn State University |
Responsible Party: | Penn State University ( Timothy Craig, D.O. ) |
Study ID Numbers: | 25325, 25325 |
Study First Received: | June 24, 2008 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00704496 |
Health Authority: | United States: Institutional Review Board |
Sleep, Pseudoephedrine |
Naphazoline Pseudoephedrine Oxymetazoline Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Guaifenesin Phenylephrine Ephedrine Rhinitis Phenylpropanolamine |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Physiological Effects of Drugs Anti-Asthmatic Agents Central Nervous System Stimulants Cardiovascular Agents |
Nose Diseases Pharmacologic Actions Nasal Decongestants Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |