Allergic Rhinitis Combination Pharmacotherapy Efficacy Study

NCT ID: NCT04601324

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2021-07-01

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Azelastine hydrochloride and fluticasone propionate

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Fluticasone Propionate

Intervention Type: DRUG

Participants will be required to use fluticasone propionate nasal spray twice daily.

Rupatadine

Intervention Type: DRUG

Rupatadine once daily for a total of 2 weeks.

Interventions

Fluticasone Propionate

Participants will be required to use fluticasone propionate nasal spray twice daily.

Intervention Type: 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.

Intervention Type: DRUG

Rupatadine

Rupatadine once daily for a total of 2 weeks.

Intervention Type: DRUG

Other Intervention Names

Flonase; Dymista; RUPALL

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Paul's Sinus Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Andrew Thamboo, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Allergic Rhinitis Protocol

Identifier Type: -

Identifier Source: org_study_id