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

NCT01469234 | Completed Phase 4 Results

• 3 other identifiers: 18126PT11-37P08712
• Study Type: interventional
• Target: 255
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)

  The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.

  From time of sensitization (time 0) to end of visit (~8 hours)

Secondary Outcomes (7)

• Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point

  From time of sensitization (time 0) to end of visit (~8 hours)

• Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point

  From time of sensitization (time 0) to end of visit (~8 hours)

• Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point

  From time of sensitization (time 0) to end of visit (~8 hours)

• Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point

  From time of sensitization (time 0) to end of visit (~8 hours)

• Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point

  From time of sensitization (time 0) to end of visit (~8 hours)

Study Arms (3)

loratadine

EXPERIMENTAL

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

Drug: loratadine; Drug: placebo to fexofenadine

fexofenadine

EXPERIMENTAL

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

Drug: fexofenadine; Drug: placebo to loratadine

placebo

PLACEBO COMPARATOR

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

Drug: placebo to loratadine; Drug: placebo to fexofenadine

Interventions

loratadine DRUG

loratadine, one 10 mg tablet, orally

Also known as: SCH 029851

loratadine

fexofenadine DRUG

fexofenadine, one 180 mg tablet, orally

fexofenadine

placebo to loratadine DRUG

one tablet, orally

fexofenadine; placebo

placebo to fexofenadine DRUG

one tablet, orally

loratadine; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Rhinitis

Interventions

Loratadine; fexofenadine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 10, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 11, 2015
• Results First Posted: March 22, 2013

Record last verified: 2015-02