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

Bayer

Status and phase: Completed; Phase 4

Conditions: Rhinitis, Allergic

Treatments: Drug: Placebo spray; Drug: Placebo tablet; Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D); Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03443843

19880

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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82 participants in 4 patient groups

Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: Fluticasone Propionate

Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

Drug: Placebo tablet

Drug: Placebo spray

Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: Fluticasone Propionate

Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

Drug: Placebo tablet

Drug: Placebo spray

Sequence 3

Experimental group

Description:

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.

Treatment:

Drug: Fluticasone Propionate

Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

Drug: Placebo tablet

Drug: Placebo spray

Sequence 4

Experimental group

Description:

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.

Treatment:

Drug: Fluticasone Propionate

Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

Drug: Placebo tablet

Drug: Placebo spray