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

December 18, 2019 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Treatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of each of the 4 treatments.
Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)
Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally
Drug: Placebo tablet
Placebo tablet orally
Drug: Fluticasone Propionate
Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril
Drug: Placebo spray
Placebo Nasal Spray, 2 sprays per nostril
Experimental: Sequence 2
Treatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of each of the 4 treatments.
Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)
Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally
Drug: Placebo tablet
Placebo tablet orally
Drug: Fluticasone Propionate
Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril
Drug: Placebo spray
Placebo Nasal Spray, 2 sprays per nostril
Experimental: Sequence 3
Treatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of treatment each of the 4 treatments.
Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)
Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally
Drug: Placebo tablet
Placebo tablet orally
Drug: Fluticasone Propionate
Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril
Drug: Placebo spray
Placebo Nasal Spray, 2 sprays per nostril
Experimental: Sequence 4
Treatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of treatment each of the 4 treatments.
Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)
Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally
Drug: Placebo tablet
Placebo tablet orally
Drug: Fluticasone Propionate
Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril
Drug: Placebo spray
Placebo Nasal Spray, 2 sprays per nostril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average percent change in PNIF (Peak Nasal Inspiratory Flow) from 0 to 4 hours after dosing
Time Frame: Up to 4 hours
Up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2018

Primary Completion (Actual)

May 11, 2018

Study Completion (Actual)

May 11, 2018

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 18, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19880

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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