Back to resultsThe Effect of Pseudoephedrine on Rhinitis and Sleep
Primary Purpose
Rhinitis, Sleep
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pseudoephedrine
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis focused on measuring Sleep, Pseudoephedrine
Eligibility 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
Sites / Locations
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Pseudoephedrine
Arm Description
Placebo
Pseudoephedrine is a 240 mg PO per day
Outcomes
Primary Outcome Measures
Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo
sleep improvement by subjective questionnaires
Secondary Outcome Measures
Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo
daytime sleepiness by subjective questionnaires
Full Information
NCT ID
NCT00704496
First Posted
June 24, 2008
Last Updated
September 20, 2017
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00704496
Brief Title
The Effect of Pseudoephedrine on Rhinitis and Sleep
Official Title
The Effect of Pseudoephedrine on Rhinitis and Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Sleep
Keywords
Sleep, Pseudoephedrine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Pseudoephedrine
Arm Type
Active Comparator
Arm Description
Pseudoephedrine is a 240 mg PO per day
Intervention Type
Drug
Intervention Name(s)
Pseudoephedrine
Other Intervention Name(s)
Placebo
Intervention Description
Pseudoephedrine is a 240 mg PO per day
Primary Outcome Measure Information:
Title
Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo
Description
sleep improvement by subjective questionnaires
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo
Description
daytime sleepiness by subjective questionnaires
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J Craig, D.O.
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
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The Effect of Pseudoephedrine on Rhinitis and Sleep
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