Allergic Rhinitis Combination Pharmacotherapy Efficacy Study

Allergic Rhinitis Clinical Trial

Official title:

Randomized Controlled Trial Evaluating Combination Rupatadine and Fluticasone Propionate Compared to Azelastine Hydrochloride and Fluticasone Propionate in Treating Allergic Rhinitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04601324
• Other study ID #: Allergic Rhinitis Protocol
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 15, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2023
• Source: St. Paul's Sinus Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Fluticasone Propionate
Participants will be required to use fluticasone propionate nasal spray twice daily.
• 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.
• Rupatadine
Rupatadine once daily for a total of 2 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Paul's Sinus Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Reflective Total Nasal Symptom Score (TNSS)	Score range of 0 to 12, higher scores indicate worse symptoms	2 weeks
Secondary	Change in Individual reflective nasal symptoms score (iTNSS)	Score range of 0 to 12, higher scores indicate worse symptoms	2 weeks
Secondary	Change in reflective total ocular symptoms score (rTOSS)	Score range of 0 to 12, higher scores indicate worse symptoms	2 weeks
Secondary	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
Secondary	Adverse Events	Patient reported adverse events	2 weeks