The Effect of Pseudoephedrine on Rhinitis and Sleep

• ClinicalTrials.gov Identifier: NCT00704496
• Recruitment Status: Completed
• First Posted: June 25, 2008
• Results First Posted: October 18, 2017
• Last Update Posted: October 18, 2017
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): Timothy Craig, Milton S. Hershey Medical Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Rhinitis; Sleep	Drug: Pseudoephedrine	Phase 3

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

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

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
• Other Study ID Numbers: 25325
• First Posted: June 25, 2008
• 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; 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