Clinical trial NCT04601324: Allergic Rhinitis Combination Pharmacotherapy Efficacy Study
Official title: Randomized Controlled Trial Evaluating Combination Rupatadine and Fluticasone Propionate Compared to Azelastine Hydrochloride and Fluticasone Propionate in Treating Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
Oral Antihistamine
Nasal Steroid
Nasal Antihistamine Spray
Lead sponsor: St. Paul's Sinus Centre
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Reflective Total Nasal Symptom Score (TNSS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in Individual reflective nasal symptoms score (iTNSS)
timeFrame: 2 weeks
measure: Change in reflective total ocular symptoms score (rTOSS)
timeFrame: 2 weeks
measure: Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: 6 weeks
measure: Adverse Events
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References: