A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)

Bayer

Status and phase: Completed; Phase 4

Conditions: Rhinitis

Treatments: Drug: fexofenadine; Drug: placebo to fexofenadine; Drug: loratadine; Drug: placebo to loratadine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01469234

PT11-37 (Other Identifier)

P08712 (Other Identifier)

18126

Details and patient eligibility

About

The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and

Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female participants of child bearing potential must demonstrate a negative

urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study.

• Willing to stop use of current decongestant and allergy medications at the start of the washout period (Visit 1) and during the trial.
• Documented history or participant-reported history of seasonal allergic rhinitis caused by mountain cedar pollen within the last 2 years and documented or participant-reported symptoms over at least the last 2 mountain cedar allergy seasons.
• Documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the last 1 year to mountain cedar pollen present.
• Capable of reading English.
• Body mass index (BMI) <35.

Exclusion criteria

• Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, fexofenadine or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.
• Have started allergen immunotherapy within 1 month preceding enrollment or participants starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.
• Known allergy or intolerance to loratadine, desloratadine, or fexofenadine.
• History of rhinitis medicamentosa.
• Use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone is permitted), or nasal corticosteroids in the last 30 days or current or expected use of disallowed medications as listed in the protocol.
• Asthma, with the exception of mild intermittent asthma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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255 participants in 3 patient groups, including a placebo group

loratadine

Experimental group

Description:

Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.

Treatment:

Drug: loratadine

Drug: placebo to fexofenadine

fexofenadine

Experimental group

Description:

Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.

Treatment:

Drug: placebo to loratadine

Drug: fexofenadine

placebo

Placebo Comparator group

Description:

Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.

Treatment:

Drug: placebo to loratadine

Drug: placebo to fexofenadine