Allergic RhinitisPhase 4NCT04601324
Allergic Rhinitis Combination Pharmacotherapy Efficacy Study
A Phase 4 study testing Fluticasone Propionate, Azelastine hydrochloride and fluticasone propionate and Rupatadine in people with Allergic Rhinitis, run by St. Paul's Sinus Centre.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Fluticasone Propionate, Azelastine hydrochloride and fluticasone propionate and Rupatadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2020to 1 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Randomized Controlled Trial Evaluating Combination Rupatadine and Fluticasone Propionate Compared to Azelastine Hydrochloride and Fluticasone Propionate in Treating Allergic Rhinitis
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).
Read the 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
- Being tested
- Fluticasone Propionate, Azelastine hydrochloride and fluticasone propionate, Rupatadine
- Keywords
- Allergic Rhinitis, Oral Antihistamine, Nasal Steroid, Nasal Antihistamine Spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
Also called Flonase
Participants will be required to use fluticasone propionate nasal spray twice daily.
Azelastine hydrochloride and fluticasone propionateDrug
Also called Dymista
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.
RupatadineDrug
Also called RUPALL
Rupatadine once daily for a total of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fluticasone Propionate; Drug: Rupatadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reflective Total Nasal Symptom Score (TNSS)
Score range of 0 to 12, higher scores indicate worse symptoms
Measured: 2 weeks
Secondary outcomes (4)
Change in Individual reflective nasal symptoms score (iTNSS)
Score range of 0 to 12, higher scores indicate worse symptoms
Measured: 2 weeks
Change in reflective total ocular symptoms score (rTOSS)
Score range of 0 to 12, higher scores indicate worse symptoms
Measured: 2 weeks
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
Measured: 6 weeks
Adverse Events
Patient reported adverse events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start15 Dec 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Why it stopped: PI did not pursue this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul's Sinus Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andrew Thamboo, MD, St. Paul's Sinus Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601324
- Sponsor's protocol ID
- Allergic Rhinitis Protocol
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating Combination Rupatadine and Fluticasone Propionate Compared to Azelastine Hydrochloride and Fluticasone Propionate in Treating Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT04601324
- Acronym / sponsor ID
- Allergic Rhinitis Protocol
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Oral Antihistamine, Nasal Steroid, Nasal Antihistamine Spray
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI did not pursue this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Paul's Sinus CentreUniversity, hospital or other
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dymista (Azelastine hydrochloride and fluticasone propionate) | Active comparator | Drug: Azelastine hydrochloride and fluticasone propionateParticipants 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 | Experimental | Drug: Fluticasone Propionate, Drug: RupatadineParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone PropionateAlso: FlonaseParticipants will be required to use fluticasone propionate nasal spray twice daily. | Drug | Fluticasone Propionate and Rupatadine |
| Azelastine hydrochloride and fluticasone propionateAlso: DymistaParticipants 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. | Drug | Dymista (Azelastine hydrochloride and fluticasone propionate) |
| RupatadineAlso: RUPALLRupatadine once daily for a total of 2 weeks. | Drug | Fluticasone Propionate and Rupatadine |
Primary outcome
Change in Reflective Total Nasal Symptom Score (TNSS)
Time frame: 2 weeks
Score range of 0 to 12, higher scores indicate worse symptoms
4 secondary outcomes
Change in Individual reflective nasal symptoms score (iTNSS)
Time frame: 2 weeks
Change in reflective total ocular symptoms score (rTOSS)
Time frame: 2 weeks
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: 6 weeks
Adverse Events
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone Propionate, Azelastine hydrochloride and fluticasone propionate and Rupatadine in people with Allergic Rhinitis, run by St. Paul's Sinus Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reflective Total Nasal Symptom Score (TNSS) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.