The Effect of Pseudoephedrine on Rhinitis and Sleep

Sleep Clinical Trial

Official title:

The Effect of Pseudoephedrine on Rhinitis and Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704496
• Other study ID #: 25325
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2008
• Last updated: September 20, 2017
• Start date: June 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Sleep

Intervention

Drug:
• Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo	sleep improvement by subjective questionnaires	3 years
Secondary	Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo	daytime sleepiness by subjective questionnaires	3 years