Phase 3
Completed N=34
The Effect of Pseudoephedrine on Rhinitis and Sleep
Rhinitis · Sleep
Source: ClinicalTrials.gov NCT00704496 ↗
Enrolled (actual)
34
Serious AEs
—
Results posted
Oct 2017
Primary outcomePrimary: Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo |
— | — |
| SECONDARY Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00704496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.