Allergic Rhinitis Combination Pharmacotherapy Efficacy Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Fluticasone Propionate
* Drug: Azelastine hydrochloride and fluticasone propionate
* Drug: Rupatadine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over the age of 18 Positive allergy skin prick test that diagnose AR Persistent and Moderate-to-Severe AR (Persistent symptoms for more than 6 weeks and suffers from abnormal sleep, impairment of daily activities, work-school problems, or has troublesome symptoms; TNSS of at least 8/12) Negative CT sinus Exclusion Criteria: Non-Allergic Rhinitis patients will be excluded from this study. Participants who are pregnant or lactating Hypersensitivity to FP, MP-AzeFlu, or Rupatadine Superficial or moderate nasal erosion, nasal mucosal ulceration or nasal septum perforation, who had nasal surgery within the last year, had significant pulmonary disease (excluding intermittent asthma) Participants who had inferior turbinate reduction surgery Participants who smoke Not able to read and understand the consent form Patients suffering from nonallergic rhinitis (eg. vasomotor, infectious, or drug-induced rhinitis) or with a negative skin prick test will not be included

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dymista (Azelastine hydrochloride and fluticasone propionate)<br>Participants will receive standard of care, which includes twice daily MP-AzeFlu nasal spray (formulation of 137 mg of azelastine hydrochloride and 50 mcg of fluticasone propionate per spray) separated by 12 hours. | Drug: Azelastine hydrochloride and fluticasone propionate<br>* 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.<br>* Other names: Dymista;|
| Experimental: Fluticasone Propionate and Rupatadine<br>Participants will administer fluticasone propionate nasal spray once daily (2 sprays in each nostril, 50 mcg fluticasone propionate per spray)and 1 tablet of Rupatadine (10mg) once daily in the morning. | Drug: Fluticasone Propionate<br>* Participants will be required to use fluticasone propionate nasal spray twice daily.<br>* Other names: Flonase;Drug: Rupatadine<br>* Rupatadine once daily for a total of 2 weeks.<br>* Other names: RUPALL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Reflective Total Nasal Symptom Score (TNSS) | Score range of 0 to 12, higher scores indicate worse symptoms | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Individual reflective nasal symptoms score (iTNSS) | Score range of 0 to 12, higher scores indicate worse symptoms | 2 weeks | 
| Change in reflective total ocular symptoms score (rTOSS) | Score range of 0 to 12, higher scores indicate worse symptoms | 2 weeks | 
| Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Score range of 0 to 168, split into 7 sections, higher the score relates to more negative impact on QoL | 6 weeks | 
| Adverse Events | Patient reported adverse events | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic Rhinitis, Oral Antihistamine, Nasal Steroid, Nasal Antihistamine Spray