Allergic Rhinitis
Conditions
Keywords
Allergic rhinitis; intranasal corticosteroids; combination therapy
Brief 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. 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.
Interventions
Intranasal fluticasone propionate is administered according to standard dosing recommendations for the treatment of moderate-to-severe allergic rhinitis.
DRUGFluticasone propionate-azelastine nasal spray
Fixed-dose intranasal combination of fluticasone propionate and azelastine hydrochloride administered according to recommended dosing schedules.
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label study. Both participants and investigators were aware of the assigned treatments, and no blinding was applied.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed