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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

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ClinicalTrials.gov Identifier: NCT03443843
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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
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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

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443843


Locations
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Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Bayer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03443843    
Other Study ID Numbers: 19880
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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