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

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 |
- Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo [ Time Frame: 3 years ]sleep improvement by subjective questionnaires
- 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 |
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

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
United States, Pennsylvania | |
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Timothy J Craig, D.O. | Penn State University |
Responsible Party: | Timothy Craig, Timothy Craig, D.O., Milton S. Hershey Medical Center |
ClinicalTrials.gov Identifier: | NCT00704496 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Sleep, Pseudoephedrine |
Rhinitis Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases 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 |