Allergic Rhinitis Combination Pharmacotherapy Efficacy Study

NCT04601324 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Allergic Rhinitis Protocol
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis; Oral Antihistamine; Nasal Steroid; Nasal Antihistamine Spray

Outcome Measures

Primary Outcomes (1)

• Change in Reflective Total Nasal Symptom Score (TNSS)

  Score range of 0 to 12, higher scores indicate worse symptoms

  2 weeks

Secondary Outcomes (4)

• Change in Individual reflective nasal symptoms score (iTNSS)

  2 weeks

• Change in reflective total ocular symptoms score (rTOSS)

  2 weeks

• Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

  6 weeks

• Adverse Events

  2 weeks

Study Arms (2)

Dymista (Azelastine hydrochloride and fluticasone propionate)

ACTIVE COMPARATOR

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

Fluticasone Propionate and Rupatadine

EXPERIMENTAL

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; Drug: Rupatadine

Interventions

Fluticasone Propionate DRUG

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

Also known as: Flonase

Fluticasone Propionate and Rupatadine

Azelastine hydrochloride and fluticasone propionate 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.

Also known as: Dymista

Dymista (Azelastine hydrochloride and fluticasone propionate)

Rupatadine DRUG

Rupatadine once daily for a total of 2 weeks.

Also known as: RUPALL

Fluticasone Propionate and Rupatadine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Paul's Sinus Centre: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Fluticasone; azelastine; rupatadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: December 15, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 31, 2023

Record last verified: 2023-10