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Completed

NCT Number: NCT03443843

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

Drug

Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally

Placebo Tablet

Drug

Placebo tablet orally

Fluticasone propionate

Drug

Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril

Placebo Spray

Drug

Placebo Nasal Spray, 2 sprays per nostril

Primary outcomes

  1. Average percent change in PNIF (Peak Nasal Inspiratory Flow) from 0 to 4 hours after dosing

    Time frame: Up to 4 hours

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Double-Blind Placebo-Controlled Crossover Study to Evaluate Objective Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure in an Environmental Exposure Unit

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2018
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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