NCT04601324

Allergic Rhinitis Combination Pharmacotherapy Efficacy Study

Randomized Controlled Trial Evaluating Combination Rupatadine and Fluticasone Propionate Compared to Azelastine Hydrochloride and Fluticasone Propionate in Treating Allergic Rhinitis

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: St. Paul's Sinus Centre · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate	Participants will be required to use fluticasone propionate nasal spray twice daily.
DRUG	Azelastine hydrochloride and fluticasone propionate	Participants will be required to administer twice daily MP-AzeFlu nasal spray (formulation of 137 mg of azelastine hydrochloride/50 mg of fluticasone propionate) separated by 12 hours.
DRUG	Rupatadine	Rupatadine once daily for a total of 2 weeks.

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-06-01
• Completion: 2021-07-01
• First posted: 2020-10-23
• Last updated: 2023-10-31

Regulatory

• FDA-regulated drug study