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

NCT00638118 | Completed Phase 4

• 1 other identifier: M016455A_4146
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Size of change in skin flares from baseline will be measured.

  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 Outcomes (1)

• Size of change in skin wheals from baseline will be measured.

  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)

Interventions

Fexofenadine DRUG

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Phyllis Diener

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 18, 2008
• Study Start: February 1, 2003
• Study Completion: May 1, 2003
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)