Allergic RhinitisPhase 4NCT07415278
INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION
A Phase 4 study testing Fluticasone propionate nasal spray and Fluticasone propionate-azelastine nasal spray in people with Allergic Rhinitis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This prospective comparative study was conducted to evaluate the clinical efficacy, onset of action, and side-effect profiles of intranasal fluticasone propionate (FP) monotherapy and a fluticasone propionate-azelastine (MP-AzeFlu) combination in adult patients with moderate-to-severe allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Fluticasone propionate nasal spray and Fluticasone propionate-azelastine nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 30 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Clinical symptoms consistent with allergic rhinitis
- Positive skin prick test results
- Moderate-to-severe allergic rhinitis defined as a Score for Allergic Rhinitis (SFAR) of 7 or higher
- Willingness to participate and provide informed consent
Who cannot join
- Patients under 18 years of age
- Patients with atopic diseases (e.g., atopic dermatitis) or asthma, other than allergic rhinitis
- Those with a recent respiratory tract infection, nasal polyps, or septal deviation
- Patients who had previously undergone sinonasal surgical treatment
- Individuals who use tobacco, alcohol, or illicit drugs
- Those who have used the following medications:
- Antihistamines (within the last week) Nasal or oral decongestants (within the last week) Topical corticosteroids (within the last 2 weeks) Membrane stabilizers (within the last 2 weeks) Leukotriene antagonists (within the last 2 weeks) Systemic corticosteroids (past 4 weeks) Immunotherapy (within the past 5 years)
- Patients with allergic rhinitis symptom score <7
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20070
About this study
Official title: INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION AS FIRST-LINE THERAPY IN ALLERGIC RHINITIS: A PROSPECTIVE COMPARATIVE STUDY
This prospective comparative study was conducted to evaluate the clinical efficacy, onset of action, and side-effect profiles of intranasal fluticasone propionate (FP) monotherapy and a fluticasone propionate-azelastine (MP-AzeFlu) combination in adult patients with moderate-to-severe allergic rhinitis. Patients with positive skin prick test results were randomly assigned to receive either FP monotherapy or MP-AzeFlu combination therapy. Symptom severity and quality of life were assessed at baseline, day 7, month 1, and month 2 using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a visual analog scale (VAS). The primary objective was to compare changes in quality-of-life scores between treatment groups. Secondary outcomes included onset of symptom relief and treatment-related sensory side effects.
Read the detailed description
Allergic rhinitis (AR) is a chronic inflammatory condition of the nasal mucosa that significantly affects patients' quality of life, sleep, and daily functioning. Intranasal corticosteroids are recommended as first-line therapy for moderate-to-severe AR; however, some patients experience delayed symptom relief or insufficient control. Combination therapy with an intranasal antihistamine and corticosteroid may provide faster and more effective symptom control, but comparative data on onset of action, quality-of-life outcomes, and side-effect profiles are limited.
This prospective, randomized, comparative clinical study was conducted at a tertiary care otorhinolaryngology clinic. Adult patients presenting with symptoms of allergic rhinitis and positive skin prick test results were screened. Patients with moderate-to-severe symptoms, defined by a Score for Allergic Rhinitis (SFAR) of 7 or higher, were included. Eligible participants were randomly assigned to one of two treatment groups: intranasal fluticasone propionate (FP) monotherapy or a fixed-dose combination of fluticasone propionate and azelastine hydrochloride (MP-AzeFlu). Treatments were administered according to the recommended dosing schedules.
Patients were evaluated at baseline and at day 7, month 1, and month 2 after treatment initiation. Clinical efficacy and quality of life were assessed using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a visual analog scale (VAS). The onset of action was defined as the first day on which patients reported noticeable symptom improvement. Adverse effects, particularly taste and smell disturbances, were also evaluated using VAS scores. The primary objective was to compare changes in quality-of-life scores between the two treatment groups, while secondary objectives included onset of symptom relief and the assessment of treatment-related side effects.
- Conditions
- Allergic Rhinitis
- Being tested
- Fluticasone propionate nasal spray, Fluticasone propionate-azelastine nasal spray
- Keywords
- Allergic rhinitis; intranasal corticosteroids; combination therapy
- 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 propionate nasal sprayDrug
Intranasal fluticasone propionate is administered according to standard dosing recommendations for the treatment of moderate-to-severe allergic rhinitis.
Fluticasone propionate-azelastine nasal sprayDrug
Fixed-dose intranasal combination of fluticasone propionate and azelastine hydrochloride administered according to recommended dosing schedules.
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Propionate Monotherapy | Experimental | Drug: Fluticasone propionate nasal spray Receives: Drug: Fluticasone propionate nasal spray |
| Fluticasone-Azelastine Combination | Experimental | Drug: Fluticasone propionate-azelastine nasal spray Receives: Drug: Fluticasone propionate-azelastine nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score
Change in the total score of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) from baseline to 2 months after treatment initiation.
Measured: Baseline to Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Dec 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2026 (estimated)
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
- Model description
- Participants with moderate-to-severe allergic rhinitis were randomly assigned to one of two parallel treatment groups: intranasal fluticasone propionate monotherapy or a fixed-dose combination of fluticasone propionate and azelastine hydrochloride. Each group received its assigned treatment throughout the 2-month study period without crossover.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdem Mengi, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415278
- Sponsor's protocol ID
- 60116787-020-308649
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared to protect participant confidentiality and in accordance with institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION AS FIRST-LINE THERAPY IN ALLERGIC RHINITIS: A PROSPECTIVE COMPARATIVE STUDY
- ClinicalTrials.gov ID
- NCT07415278
- Acronym / sponsor ID
- 60116787-020-308649
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis; intranasal corticosteroids; combination therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 17 Feb 2026 (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.
This prospective comparative study was conducted to evaluate the clinical efficacy, onset of action, and side-effect profiles of intranasal fluticasone propionate (FP) monotherapy and a fluticasone propionate-azelastine (MP-AzeFlu) combination in adult patients with moderate-to-severe allergic rhinitis. Patients with positive skin prick test results were randomly assigned to receive either FP monotherapy or MP-AzeFlu combination therapy. Symptom severity and quality of life were assessed at baseline, day 7, month 1, and month 2 using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a visual analog scale (VAS). The primary objective was to compare changes in quality-of-life scores between treatment groups. Secondary outcomes included onset of symptom relief and treatment-related sensory side effects.
Detailed description
Allergic rhinitis (AR) is a chronic inflammatory condition of the nasal mucosa that significantly affects patients' quality of life, sleep, and daily functioning. Intranasal corticosteroids are recommended as first-line therapy for moderate-to-severe AR; however, some patients experience delayed symptom relief or insufficient control. Combination therapy with an intranasal antihistamine and corticosteroid may provide faster and more effective symptom control, but comparative data on onset of action, quality-of-life outcomes, and side-effect profiles are limited.
This prospective, randomized, comparative clinical study was conducted at a tertiary care otorhinolaryngology clinic. Adult patients presenting with symptoms of allergic rhinitis and positive skin prick test results were screened. Patients with moderate-to-severe symptoms, defined by a Score for Allergic Rhinitis (SFAR) of 7 or higher, were included. Eligible participants were randomly assigned to one of two treatment groups: intranasal fluticasone propionate (FP) monotherapy or a fixed-dose combination of fluticasone propionate and azelastine hydrochloride (MP-AzeFlu). Treatments were administered according to the recommended dosing schedules.
Patients were evaluated at baseline and at day 7, month 1, and month 2 after treatment initiation. Clinical efficacy and quality of life were assessed using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a visual analog scale (VAS). The onset of action was defined as the first day on which patients reported noticeable symptom improvement. Adverse effects, particularly taste and smell disturbances, were also evaluated using VAS scores. The primary objective was to compare changes in quality-of-life scores between the two treatment groups, while secondary objectives included onset of symptom relief and the assessment of treatment-related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with moderate-to-severe allergic rhinitis were randomly assigned to one of two parallel treatment groups: intranasal fluticasone propionate monotherapy or a fixed-dose combination of fluticasone propionate and azelastine hydrochloride. Each group received its assigned treatment throughout the 2-month study period without crossover.
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Propionate Monotherapy | Experimental | Drug: Fluticasone propionate nasal sprayDrug: Fluticasone propionate nasal spray |
| Fluticasone-Azelastine Combination | Experimental | Drug: Fluticasone propionate-azelastine nasal sprayDrug: Fluticasone propionate-azelastine nasal spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years and older
- Clinical symptoms consistent with allergic rhinitis
- Positive skin prick test results
- Moderate-to-severe allergic rhinitis defined as a Score for Allergic Rhinitis (SFAR) of 7 or higher
- Willingness to participate and provide informed consent
Key exclusion criteria (8 listed)
- Patients under 18 years of age
- Patients with atopic diseases (e.g., atopic dermatitis) or asthma, other than allergic rhinitis
- Those with a recent respiratory tract infection, nasal polyps, or septal deviation
- Patients who had previously undergone sinonasal surgical treatment
- Individuals who use tobacco, alcohol, or illicit drugs
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 propionate nasal sprayIntranasal fluticasone propionate is administered according to standard dosing recommendations for the treatment of moderate-to-severe allergic rhinitis. | Drug | Fluticasone Propionate Monotherapy |
| Fluticasone propionate-azelastine nasal sprayFixed-dose intranasal combination of fluticasone propionate and azelastine hydrochloride administered according to recommended dosing schedules. | Drug | Fluticasone-Azelastine Combination |
Primary outcome
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score
Time frame: Baseline to Month 2
Change in the total score of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) from baseline to 2 months after treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared to protect participant confidentiality and in accordance with institutional and ethical regulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone propionate nasal spray and Fluticasone propionate-azelastine nasal spray in people with Allergic Rhinitis, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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 Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score (time frame: Baseline to Month 2). 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 17 Feb 2026.