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Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Rhinitis

Intervention: Fexofenadine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

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

Summary

Examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (Allegra) and montelukast sodium 10 mg (Singulair) as compared to placebo on skin wheals and flares induced by seasonal allergen.

Clinical Details

Official title: A Comparison of Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Size of change in skin flares from baseline will be measured.

Secondary outcome: Size of change in skin wheals from baseline will be measured.

Eligibility

Minimum age: 15 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects, 15 to 55 years of age, may participate.

- Subjects with a history of seasonal allergic rhinitis (due to ragweed; oak, elm or

maple; or grasses) for the previous 2 years.

- Positive seasonal allergen skin prick tests (or duplicate seasonal allergen skin

prick test) with a summation flare greater than or equal to 20 mm larger than diluent control, and summation wheal greater than or equal to 6 mm larger than diluent control at the screening visit 1 (see Appendix 17. 1); the seasonal allergen testing that results in the greatest summation flare will be used for all subsequent seasonal allergen testing.

- All female subjects must have a negative urine pregnancy test at the screening visit.

- Female subjects who are sexually active will be expected to use one of the following

birth control methods throughout the study.

- Subjects must be within 15% of normal body weight for height or a BMI less than 29. 9

(based on NHLBI guidelines).

- Subjects willing and able to adhere to visit schedules and all study requirements.

- All female subjects must have a negative urine pregnancy test at each treatment visit

(Visit 2, 4, and 6).

- Continues to meet all inclusion and exclusion criteria.

Exclusion Criteria:

- Asthma that requires treatment with medication other than an inhaled, short-acting

beta agonist.

- Significant 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.

- Subjects who have dermatographism or other skin conditions which might interfere with

the interpretation of the skin test results.

- Subjects who are receiving 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.

- Known hypersensitivity to the investigational product or to drugs with similar

chemical properties.

- Subjects who will be visiting a tanning salon during the study.

- Subjects who will need to use artificial tanning products during the study.

- Pregnancy.

- Breast-feeding.

- Regular treatment with other H1-receptor antagonists in the last year before study

entry.

- No person or child of a person directly associated with the administration of the

study may participate as a study subject.

- Likelihood of requiring treatment during the study period with drugs not permitted by

the clinical study protocol.

- 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.

- Subject unlikely to comply 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: 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; Antihistamines including 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 should only be permitted if they are not expected to interfere with the

ability of the subject to participate in the study.

- Non-steroidal anti-inflammatory agents are not allowed for 2 days prior to each

treatment visit day through 25 hours post-dose (low-dose cardiac prophylaxis is allowed).

- Use of any medications or agents that are not specified above that may confound the

interpretation of the results:

- Caffeine within 6 hours prior to each visit (coffee, tea, cola, and sodas, 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 +/- minus2 hours of investigational product dosing.

Locations and Contacts

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

Starting date: February 2003
Last updated: January 10, 2011

Page last updated: August 23, 2015

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