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

• ClinicalTrials.gov Identifier: NCT03443843
• Recruitment Status: Completed
• First Posted: February 23, 2018
• Last Update Posted: May 10, 2019
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Rhinitis, Allergic	Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D); Drug: Placebo tablet; Drug: Fluticasone Propionate; Drug: Placebo spray	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: February 21, 2018
• Actual Primary Completion Date: May 11, 2018
• Actual Study Completion Date: May 11, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Average percent change in PNIF (Peak Nasal Inspiratory Flow) from 0 to 4 hours after dosing [ Time Frame: Up to 4 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Ontario

Kingston General Hospital

Kingston, Ontario, Canada, K7L 2V7

Sponsors and Collaborators

Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03443843 History of Changes
• Other Study ID Numbers: 19880
• First Posted: February 23, 2018
• Last Update Posted: May 10, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Loratadine; Pseudoephedrine; Ephedrine; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents; Nasal Decongestants; Vasoconstrictor Agents; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action