A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure
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
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2018
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2018
CompletedStudy Start
First participant enrolled
February 21, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2018
CompletedDecember 20, 2019
December 1, 2019
3 months
February 20, 2018
December 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Average percent change in PNIF (Peak Nasal Inspiratory Flow) from 0 to 4 hours after dosing
Up to 4 hours
Study Arms (4)
Sequence 1
EXPERIMENTALTreatment 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.
Sequence 2
EXPERIMENTALTreatment 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.
Sequence 3
EXPERIMENTALTreatment 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.
Sequence 4
EXPERIMENTALTreatment 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.
Interventions
Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally
Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Related Publications (1)
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.
PMID: 34000435DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2018
First Posted
February 23, 2018
Study Start
February 21, 2018
Primary Completion
May 11, 2018
Study Completion
May 11, 2018
Last Updated
December 20, 2019
Record last verified: 2019-12