Allergy
Conditions
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.
Interventions
DRUGFexofenadine HCI
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Size of change in skin flares from baseline measured at pre-specified times post-dose. | 20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points obtained at Hours 23 and 24. |
Secondary
| Measure | Time frame |
|---|---|
| Size and change in skin wheals from baseline measured at pre-specified time points. | 20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points. |
Countries
United States
Outcome results
None listed