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

NCT ID: NCT03443843

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2018-05-11

Brief Summary

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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.

Detailed Description

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Conditions

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Rhinitis, Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

Intervention Type DRUG

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

Placebo tablet

Intervention Type DRUG

Placebo tablet orally

Fluticasone Propionate

Intervention Type DRUG

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

Placebo spray

Intervention Type DRUG

Placebo Nasal Spray, 2 sprays per nostril

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.

Group Type EXPERIMENTAL

loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

Intervention Type DRUG

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

Placebo tablet

Intervention Type DRUG

Placebo tablet orally

Fluticasone Propionate

Intervention Type DRUG

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

Placebo spray

Intervention Type DRUG

Placebo Nasal Spray, 2 sprays per nostril

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.

Group Type EXPERIMENTAL

loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

Intervention Type DRUG

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

Placebo tablet

Intervention Type DRUG

Placebo tablet orally

Fluticasone Propionate

Intervention Type DRUG

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

Placebo spray

Intervention Type DRUG

Placebo Nasal Spray, 2 sprays per nostril

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.

Group Type EXPERIMENTAL

loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

Intervention Type DRUG

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

Placebo tablet

Intervention Type DRUG

Placebo tablet orally

Fluticasone Propionate

Intervention Type DRUG

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

Placebo spray

Intervention Type DRUG

Placebo Nasal Spray, 2 sprays per nostril

Interventions

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loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)

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

Intervention Type DRUG

Placebo tablet

Placebo tablet orally

Intervention Type DRUG

Fluticasone Propionate

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

Intervention Type DRUG

Placebo spray

Placebo Nasal Spray, 2 sprays per nostril

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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Ng CC, Romaikin D, Steacy LM, Stevens DA, Walker TJ, Adams DE, Ellis AK. Comparative nasal airflow with loratadine-pseudoephedrine and fluticasone nasal spray for allergic rhinitis. Ann Allergy Asthma Immunol. 2021 Sep;127(3):342-348.e2. doi: 10.1016/j.anai.2021.05.001. Epub 2021 May 14.

Reference Type DERIVED
PMID: 34000435 (View on PubMed)

Related Links

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https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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19880

Identifier Type: -

Identifier Source: org_study_id