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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Pseudoephedrine | Active Comparator | Pseudoephedrine is a 240 mg PO per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pseudoephedrine | Drug | Pseudoephedrine is a 240 mg PO per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo | sleep improvement by subjective questionnaires | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo | daytime sleepiness by subjective questionnaires | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy J Craig, D.O. | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
data disposed of and no longer in existence
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| ID | Title | Description |
|---|---|---|
| FG000 | Pseudoephedrine | Pseudoephedrine is a 240 mg PO per day |
| FG001 | Placebo | Placebo arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
data disposed of and no longer in existence
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day |
| BG001 | Pseudoephedrine | Pseudoephedrine is a 240 mg PO per day Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo | sleep improvement by subjective questionnaires | data disposed of and no longer in existence | Posted | 3 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day |
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data disposed of and no longer in existence
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| timothy craig, | milton s hershey medical center | 717-531-6525 | 1 | tcraig@psu.edu |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Secondary | Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo | daytime sleepiness by subjective questionnaires | data disposed of and no longer in existence | Posted | 3 years |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Pseudoephedrine | Pseudoephedrine is a 240 mg PO per day Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day | 0 | 0 | 0 | 0 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D020005 |
| Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |