Evaluation of Breathe-Easy Hayfever Care for Managing Symptoms in Patients With Seasonal Allergic Rhinitis

Innowage Limited1 site in 1 country63 target enrollmentApril 24, 2024

ConditionsHayfever Allergy Pollen Allergic Rhinitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hayfever
Sponsor: Innowage Limited
Enrollment: 63
Locations: 1
Primary Endpoint: Well-being Numerical Rating Scales
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This waitlist-controlled trial aims to evaluate the therapeutic effectiveness of Hayfever Care by assessing disease-specific symptoms over a 4-week period. Additionally, the study examines the tolerability and safety of the solution.

Registry

clinicaltrials.gov

Start Date

April 24, 2024

End Date

June 15, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Innowage Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Mild to moderate symptoms during the hayfever season
•Generally healthy individuals without chronic illnesses
•Willingness to comply with study requirements, including completing symptom diaries.

Exclusion Criteria

•History of anaphylaxis or severe hayfever symptoms requiring emergency treatment.
•Pregnant or breastfeeding
•History of substance abuse or excessive alcohol consumption.
•Use of systemic corticosteroids, immunotherapy

Outcomes

Primary Outcomes

Well-being Numerical Rating Scales

Time Frame: Change from Baseline to 4 weeks after baseline

Secondary Outcomes

Change of Symptom Dry Eyes(Change in symptom scores from baseline to 4 weeks.)
Change of Symptom Itching Eyes(Change in symptom scores from baseline to 4 weeks.)
Change of Symptom Burning Eyes(Change in symptom scores from baseline to 4 weeks.)
Change of Symptom Respiratory Complaints(Change in symptom scores from baseline to 4 weeks.)
Change of Symptom Sneezing(Change in symptom scores from baseline to 4 weeks.)
Change of Symptom Rhinitis(Change in symptom scores from baseline to 4 weeks.)
Change of Symptom Fatigue(Change in symptom scores from baseline to 4 weeks.)
Change of Symptom Headache(Change in symptom scores from baseline to 4 weeks.)