Allergic Rhinitis Clinical Trial
Official title:
A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-over
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Questionnaires were given to each patient after each drug dose to evaluate patient product preference.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 1, 2005 |
Est. primary completion date | January 1, 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Subject must have been 18-65 years of age, of either sex and any race. - Subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of <6 but >2; congestion must have been <2. - Subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations. - Subject must have understood and been able to adhere to the dosing and visit schedule. Exclusion Criteria: - Subject had used any investigational product within 30 days prior to enrollment. - Subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study. - Subject was participating in any other clinical study(ies). - Subject was using any nasal lavage fluid or spray. - Subject was using any perfume during the study day. - Subject was using any oral rinse during the study day. - Subject had used topical or oral nasal decongestants in the past 1 week. - Subject had used a nasal corticosteroid in the previous 2 weeks. - Subject had anosmia or ageusia (absence of the sense of smell or taste). - Subject had been using medications which are associated with anosmia or ageusia in the 2 weeks prior to testing. - Subject had a respiratory infection in the 2 weeks prior to testing. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall product preference based on subjects' answer to the question "which product do you prefer overall" | On the study day, after dose of each product | ||
Secondary | Subject ratings for individual product attributes | On the study day, after dose of each product | ||
Secondary | Subject rating for likely compliance with daily dosing, | On the study day, after dose of each product | ||
Secondary | Subject preference for glass or plastic bottle | On the study day, after dose of each product | ||
Secondary | Subject response to if they would want a prescription for their preferred product and if they would recommend the product | On the study day, after dose of each product | ||
Secondary | Subject response to whether they preferred inhaled corticosteroid with or without aftertaste, and/or scent/odor, | On the study day, after dose of each product |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05080322 -
Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis
|
Phase 4 | |
Recruiting |
NCT06028490 -
A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.
|
Phase 2 | |
Completed |
NCT04388358 -
Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation
|
N/A | |
Recruiting |
NCT04202263 -
Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline
|
Phase 2 | |
Completed |
NCT04078009 -
Standardising Nasal Allergen Challenge in Adult With Hay Fever
|
N/A | |
Completed |
NCT03644680 -
Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study
|
N/A | |
Completed |
NCT04541004 -
Adolescent Mite Allergy Safety Evaluation
|
Phase 3 | |
Recruiting |
NCT05378594 -
HDM and Silver Birch NAC Standardisation
|
N/A | |
Not yet recruiting |
NCT05684380 -
Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)
|
Phase 3 | |
Completed |
NCT02943720 -
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
|
Phase 2 | |
Not yet recruiting |
NCT01014325 -
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
|
Phase 3 | |
Completed |
NCT02910401 -
Clinical Response to Rhinovirus Challenge
|
Phase 2 | |
Completed |
NCT02556801 -
Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy
|
Phase 2 | |
Completed |
NCT02352168 -
Airway Inflammation in Children With Allergic Rhinitis and Intervention
|
N/A | |
Not yet recruiting |
NCT02233426 -
Effect of Hypertonic Solutions on Allergic Rhinitis Patients
|
N/A | |
Completed |
NCT01946035 -
Alpha-Blockers in Allergic Rhinitis (MAN 01)
|
Phase 4 | |
Completed |
NCT01918956 -
PURETHAL Birch RUSH Study
|
Phase 4 | |
Completed |
NCT01682070 -
SUBLIVAC FIX Phleum Pratense DT/DRF
|
Phase 2 | |
Recruiting |
NCT01454492 -
The Relationship Between Allergic Rhinitis and Geographic Tongue
|
N/A | |
Completed |
NCT01438463 -
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
|
Phase 2 |