A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure
A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure
The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5
 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per
 spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy
 symptoms.
Inclusion Criteria:

 -  Healthy, ambulatory male and female subjects between 18 to 65 years of age

 -  Self-reported seasonal allergic rhinitis to ragweed pollen for at least 2 years prior
 to screening

 -  Documented positive skin prick test response to common ragweed (ambrosia
 artemisiifolia) pollen at screening or within the previous 12 months conducted at
 research site (prick with wheal diameter >= 5 mm larger than the diluent response)

 -  In order to qualify to continue to treatment phase, at the end of priming phase (which
 is 3 hours), Total Symptom Score (TSS) has to be ≥ 7, with nasal congestion score
 alone ≥ 2 and change in peak nasal inspiratory flow (PNIF) has to be ≥ 15% from
 pre-prime baseline;

 -  Subject is willing to stop use of current decongestant and allergy medications at the
 start of the washout period prior to priming and during the trial

 -  At the discretion of the investigators, subjects may be considered with self-reported
 mild intermittent asthma (Using <=2 doses of SABA (short-acting beta agonists) per
 week) or exercise-induced asthma

 -  Subject is free of any clinically significant disease that required a physician´s care
 and/or would interfere with trial evaluations, procedures or participation

 -  Subject is able to repeatedly and reliably perform PNIF measurements and must achieve
 PNIF value of >=60L/min at screening

 -  Subject must be capable of reading English and willing to participate in all aspects
 of the study

 Exclusion Criteria:

 - Any significant medical condition which, in the judgment of the investigator, is a
 contraindication to the use of loratadine, pseudoephedrine and fluticasone propionate, or
 might interfere with the trial. These may include subjects with injury or surgery to the
 nose that is not fully healed, fungal infections, immunocompromised conditions (HIV,
 tuberculosis), severe nosebleeds, narrow-angle glaucoma, chickenpox measles..., severe
 facial pain or thick nasal discharge, sinusitis, constant whistling sound from the nose,
 structured abnormality of the nose, uncontrolled thyroid disease (e.g., hyperthyroidism,
 hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease ischemic heart
 disease, uncontrolled high blood pressure, symptomatic prostatic hypertrophy, bladder neck
 obstruction, hepatic insufficiency, renal disease