Overview

A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure

Status:
Completed
Trial end date:
2018-05-11
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Ephedrine
Fluticasone
Loratadine
Pseudoephedrine
Xhance
Criteria
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