Allergic Rhinitis Combination Pharmacotherapy Efficacy Study

Phase 4

Withdrawn

• Conditions: Allergic Rhinitis
• Interventions: Drug: Azelastine hydrochloride and fluticasone propionate; Drug: Fluticasone Propionate; Drug: Rupatadine

• Registration Number: NCT04601324
• Lead Sponsor: St. Paul's Sinus Centre

Brief 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.

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-23
• Study Start: 2020-12-15
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dymista (Azelastine hydrochloride and fluticasone propionate)	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.
Fluticasone Propionate and Rupatadine	Fluticasone Propionate	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.
Fluticasone Propionate and Rupatadine	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.

Primary Outcome Measures

Name	Time	Method
Change in Reflective Total Nasal Symptom Score (TNSS)	2 weeks	Score range of 0 to 12, higher scores indicate worse symptoms

Secondary Outcome Measures

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