Allergic Rhinitis Combination Pharmacotherapy Efficacy Study

Status Withdrawn

Clinical Trial Summary

Combination pharmacotherapy is often used in people who have failed mono-therapies in managing their bothersome allergic rhinitis symptoms . However, there is a paucity of research indicating the most effective combination therapies in managing allergic rhinitis. This study aims to evaluate the efficacy of oral antihistamine (rupatadine) combined with nasal steroid (fluticasone propionate) compared to a well-studied combination therapy of nasal steroid with nasal antihistamine spray (MP-AzeFlu).

Clinical Trial Description

Allergic rhinitis is a common inflammatory disorder of the nose that is increasing in prevalence worldwide. Symptoms of allergic rhinitis has a significant negative impact on an individual's quality of life. When the symptoms are not well managed with allergen avoidance and first line pharmacotherapies, patients often resort to using a combination of medications. Physicians may recommend combination therapies to patients with moderate-to-severe allergic rhinitis, however, there is a scarcity of research indicating efficacy of combination therapy use. The investigators of this study aim to evaluate the efficacy of combining oral antihistamine (rupatadine) with nasal steroid (fluticasone propionate) compared to a well-studied combination therapy of nasal steroid with nasal antihistamine spray (MP-AzeFlu) in people suffering from medium-to-severe allergic rhinitis. Oral rupatadine is a potent antihistamine and platelet activating factor (PAF) antagonist, which has not been studied in combination therapy in allergic rhinitis. Fluticasone propionate is a well established, first line nasal steroid. Adults 19 years or older, seen in the Principal Investigator's office presenting with moderate-to-severe allergic rhinitis will be identified by the principal investigator and invited to participate in this prospective study. Patients will be recruited into the study in a consecutive manner. After providing consent, baseline characteristics will be collected. The investigator aims to recruit 51 patients in each study group respectively. Descriptive statistics will be used to analyze the baseline characteristic data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04601324
Study type	Interventional
Source	St. Paul's Sinus Centre
Contact
Status	Withdrawn
Phase	Phase 4
Start date	December 15, 2020
Completion date	July 1, 2021

View Details

See also
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
Completed	`NCT02910401` - Clinical Response to Rhinovirus Challenge	Phase 2
Not yet recruiting	`NCT01014325` - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy	Phase 3
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.