Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: fexofenadine HCl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Phyllis Diener, Study Director, Affiliation: Sanofi-Aventis

To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks) mean change from baseline in total number of errors (commission errors + omission errors) between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also will be assessed.

Official title: Single Center, Randomized,Double-Blind,Crossover Study Comparing the Effects of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel

Study design: Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Compare the AVT overall mean challenge from baseline between Fexofenadine HCl & Cetirizine

Secondary outcome: Evaluating change from baseline between Fexofenadine HCl and Cetirizine on the endpoint of total # of errors under each normobaric hypoxic condition

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female naval flight personnel, ≥18 years of age

- CogScreen-AE Logistic Regression Probability Value < 0. 6 at the baseline screening

visit

- Normal SaO2 (>95%) as measured by pulse oximetry

- Female subjects must be of nonchildbearing potential (i. e., surgically sterile or at

least 1 year postmenopausal); see Section 4. 4 for additional information:

Exclusion Criteria:

- Female subjects who are pregnant, lactating, or likely to become pregnant during the

study

- Signs or symptoms of currently active allergic disease (seasonal allergic rhinitis,

perennial allergic rhinitis, episodic allergic rhinitis) within 2 weeks prior to the screening visit

- Upper respiratory tract infection, sinusitis, asthma exacerbation, or flu-like

symptoms within 2 weeks prior to the screening visit

- Medical history or physical examination findings; clinically significant

cardiovascular, respiratory, hepatic, neurologic, endocrine, psychiatric, or other major systemic disease; or laboratory or electrocardiograph abnormality making implementation of the protocol or interpretation of the protocol results difficult. Abnormalities which are not clinically significant will not necessarily disqualify subjects provided, in the opinion of the investigator and sponsor, the study validity or the subject's welfare is not compromised.

- Any unusual sleep pattern, including third-shift workers (11: 00 PM to 7: 00 AM), or

sleep < 6 hours the night before each AVT testing at Visits 1-4

- Any excessive amounts of alcohol (no more than two drinks/day on average)

- Any excessive use of caffeine (more than three cups of coffee per day or equivalent)

- Any history of chronic alcohol or mood-altering drug abuse

- Any use of tobacco/nicotine products within 90 days of the screening visit or during

the study

- Any disease state or surgery known to affect the gastrointestinal absorption of drugs

- Mental capacity limited to the extent the subject cannot give legal informed consent

or accurate information regarding efficacy and side effects/tolerance of drug

- Subjects unable to comply with the protocol requirements (must complete a screening

visit and Visits 1-4 within approximately 1-1/2 months)

- Known hypersensitivity to fexofenadine, or the tablet ingredients (croscarmellose

sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch; or the tablet coating made of hydroxypropyl methylcellulose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide)

- Known hypersensitivity to cetirizine or the tablet ingredients (lactose, magnesium

stearate, povidone, titanium dioxide, hydroxypropyl methylcellulose, polyethylene glycol, and corn starch)

- Use of an investigational drug within 30 days prior to Visit 1

Sanofi-Aventis, Bridgewater, New Jersey 08807, United States

clinicalstudyresults.org

Starting date: September 2003
Ending date: January 2005
Last updated: March 17, 2008