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

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).

Study Overview

• Status: Withdrawn
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Azelastine hydrochloride and fluticasone propionate; Drug: Fluticasone Propionate; Drug: Rupatadine

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patient over the age of 18
2. Positive allergy skin prick test that diagnose AR
3. 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)
4. Negative CT sinus

Exclusion Criteria:

1. Non-Allergic Rhinitis patients will be excluded from this study.
2. Participants who are pregnant or lactating
3. Hypersensitivity to FP, MP-AzeFlu, or Rupatadine
4. 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)
5. Participants who had inferior turbinate reduction surgery
6. Participants who smoke
7. Not able to read and understand the consent form
8. Patients suffering from nonallergic rhinitis (eg. vasomotor, infectious, or drug-induced rhinitis) or with a negative skin prick test will not be included

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dymista (Azelastine hydrochloride and fluticasone propionate); 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; 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.; Other Names: Dymista
Experimental: Fluticasone Propionate and Rupatadine; 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; Participants will be required to use fluticasone propionate nasal spray twice daily.; Other Names: Flonase; Drug: Rupatadine; Rupatadine once daily for a total of 2 weeks.; Other Names: RUPALL

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Paul's Sinus Centre

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2020
• Primary Completion (Estimated): June 1, 2021
• Study Completion (Estimated): July 1, 2021

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Allergic Rhinitis; Oral Antihistamine; Nasal Steroid; Nasal Antihistamine Spray
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Lipoxygenase Inhibitors; Fluticasone; Xhance; Azelastine
• Other Study ID Numbers: Allergic Rhinitis Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes