The Effect of Pseudoephedrine on Rhinitis and Sleep

NCT00704496 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 25325
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis; Sleep

Keywords

Sleep, Pseudoephedrine

Outcome Measures

Primary Outcomes (1)

• Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo

  sleep improvement by subjective questionnaires

  3 years

Secondary Outcomes (1)

• Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo

  3 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Pseudoephedrine

Pseudoephedrine

ACTIVE COMPARATOR

Pseudoephedrine is a 240 mg PO per day

Drug: Pseudoephedrine

Interventions

Pseudoephedrine DRUG

Pseudoephedrine is a 240 mg PO per day

Also known as: Placebo

Placebo; Pseudoephedrine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Rhinitis

Interventions

Pseudoephedrine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Limitations and Caveats

data disposed of and no longer in existence

Results Point of Contact

• Title: timothy craig,
• Organization: milton s hershey medical center

tcraig@psu.edu

717-531-6525

Study Officials

• Timothy J Craig, D.O.

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Timothy Craig, D.O.

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 25, 2008
• Study Start: June 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 18, 2017
• Results First Posted: October 18, 2017

Record last verified: 2017-09

Locations

US (1)