Clinical trial NCT00547768: Comparative Study Evaluating the Effects of Fexofenadine HCI 180 mg With Orange Juice Versus Placebo With Orange Juice in a Skin Wheal and Flare Challenge Model.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the effect of a single dose of fexofenadine HCl 180 mg plus orange juice versus placebo plus orange juice on the change from baseline (pre-dose) in histamine skin flares.


Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant, non-lactating female subjects; 12-55 years of age; within 15% of normal body weight for their height or had a body mass index (BMI) less than 29.9 kg/m2; positive histamine skin prick tests (or a duplicate histamine skin prick test) of summation flare \> 20 mm larger than diluent control, and summation wheal \> 6 mm larger than diluent control at the screening Visit 1.

Exclusion Criteria:

* Asthma that required treatment with medication other than an inhaled, short-acting beta agonist
* Signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis)
* Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to Visit 1
* Dermatographism or other skin conditions that might interfere with the interpretation of the skin test results
* Treatment with escalating doses of immunotherapy, oral immunotherapy, or short course (rush) immunotherapy
* Any excessive amounts of alcohol (no more than two drinks/day on average)
* Any excessive use of caffeine (more than six 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 visit 1
* Any disease state or surgery known to affect the gastrointestinal absorption of drugs
* Treatment with an H1-receptor antagonist regularly within the past year before study entry
* Known hypersensitivity to the investigational product or to drugs with similar chemical properties, or to orange juice
* Need to visit a tanning salon during the study
* Need to use artificial tanning products during the study
* Pregnancy
* Breast-feeding
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)
* Treatment with any investigational product in the last 30 days before study entry
* Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Unlikelihood of complying with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
* Use of any of the following drugs within the time indicated prior to the first dosing visit (Time prior to Visit 2):
* Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal)(30 days).
* Nasal or inhaled or ocular corticosteroids (30 days).
* Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn (14 days)
* Agents with antihistaminic/anticholinergic activity (e.g.antidepressants, antipsychotics)(14 days).
* Leukotriene pathway modifiers (Accolate®, Singulair®, Zyflo®) 10 days Ocular anti-allergy medications including lodoxamide (Alomide®), olopatadine (Patanol®), emedastine difumarate (Emadine®), levocabastine (Livostin®) (10 days).
* Non-steroidal anti-inflammatory ophthalmics including ketorolac (Acular®), flurbiprofen (Ocufen®), suprofen (Profenal®), diclofenac (Voltaren®) (10 days).
* Antihistamines including desloratadine (Clarinex®), loratadine (Claritin®)(10 days).
* Fexofenadine HCl (Allegra®), cetirizine (Zyrtec®), hydroxyzine, azelastine nasal spray (Astelin®), clemastine (7 days)
* Other short-acting antihistamines such as chlorpheniramine or drugs with antihistaminic activity (3 days).
* OTC oral antihistamines, decongestants (includes pseudoephedrine and other decongestants), or antihistamines/decongestant combinations including all cold, cough, and sleep aids (3 days).
* OTC ophthalmic decongestant, antihistamine, or decongestant/ antihistamine combinations (3 days).
* Other anticholinergic agents (3 days).
* Immunotherapy injection (1 day).
* Other drugs were to be permitted if they were not expected to interfere with the ability of the subject to participate in the study.
* Non-steroidal anti-inflammatory agents were not allowed for 2 days prior to each treatment visit day through 24 hours post-dose.
* Medications or agents not specified above that might confound the interpretation of the results were prohibited as follows:
* Caffeine within 6 hours prior to each visit (coffee, tea, cola, including Mountain Dew and Surge).
* Decaffeinated coffee, tea and colas within 6 hours of each visit
* Alcohol within 24 hours prior to each study visit.
* Chocolate within 6 hours prior to each visit.
* Antacids within + 2 hours of investigational product dosing.
* Any waiver of these inclusion and exclusion criteria required approval by the investigator and the sponsor on a case-by-case basis prior to enrolling the subject. Approval had to be documented by both the sponsor and the investigator.
* No subject was to be allowed to enroll in this study more than once.

Primary outcomes:
measure: Size of change in skin flares from baseline measured at pre-specified times post-dose.
timeFrame: 20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points obtained at Hours 23 and 24.
Secondary outcomes:
measure: Size and change in skin wheals from baseline measured at pre-specified time points.
timeFrame: 20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points.
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Phyllis Diener
role: STUDY_DIRECTOR
References: