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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00638118

Enrollment

Registered

2008-03-18

Start date

2003-02-28

Completion date

2003-05-31

Last updated

2011-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

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.

Interventions

DRUGFexofenadine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

15 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026