The trial will be conducted as a prospective, randomized, multinational, multicenter, double-blind, placebo and active controlled trial in 4 parallel-groups of patients suffering from seasonal allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
669
Mometasone furoate nasal spray (50 mcg per actuation)
Azelastine hydrochloride nasal spray (140 mcg per actuation)
Placebo nasal spray
Sandoz Investigative Site
Burgas, Bulgaria
Change from baseline in the daily Total Nasal Symptom Score (TNSS)
The benefit of the treatment with the fixed combination medicinal product Momeatsone+Azelastine nasal spray (test product) in comparison to the treatment with the individual medicinal products Mometasone nasal spray and Azelastine nasal spray (comparator products) will be assessed by comparing the change from baseline in the daily Total Nasal Symptom Score (TNSS) during the first seven days of treatment. Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary. Each symptom will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms, such that the maximum TNSS is 12.
Time frame: Baseline, Day 7
Change from baseline in the daily Total Nasal Symptom Score (TNSS)
Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary starting at Visit 1 for the baseline run-in period (3 to 5 days). The mean of the symptom scores during the last 3 days prior to Visit 2 will be used to calculate baseline symptoms. Following randomization at Visit 2, the patient will document the TNSS in the evening retrospectively for each day of treatment until treatment day 14. Each symptom will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms, such that the maximum TNSS is 12.
Time frame: Baseline, Day 14
Change from baseline in individual daily nasal symptoms
Change from baseline in individual daily nasal symptoms (nasal congestion, rhinorrhea, nasal itching and sneezing) during 7 and 14 days of treatment for all four arms will be assessed.
Time frame: Baseline, Day 7 and Day 14
Change from baseline in individual daily ocular symptoms
Ocular itching and Redness and Ocular tearing will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The symptoms will be assessed by the patient in a patient's diary starting at Visit 1. The patient will document the ocular symptoms in the evening retrospectively for each day of treatment until treatment day 14.
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Sandoz Investigative Site
Gabrovo, Bulgaria
Sandoz Investigative Site
Plovdiv, Bulgaria
Sandoz Investigative Site
Sliven, Bulgaria
Sandoz Investigative Site
Sofia, Bulgaria
Sandoz Investigative Site
Sofia, Bulgaria
Sandoz Investigative Site
Varna, Bulgaria
Sandoz Investigative Site
Aachen, Germany
Sandoz Investigative Site
Dreieich, Germany
Sandoz Investigative Site
Dresden, Germany
...and 18 more locations
Time frame: Baseline, Day 7 and Day 14
Baseline-adjusted differences in nasal obstruction assessed by peak nasal inspiratory flow measurements (PNIF)
The PNIF will be performed by means of portable In-Check Nasal flow meter using a face mask which the patient applies over the nose (without touching it) with the mouth closed. The In-Check Nasal is a portable inspiratory flow meter, measuring inspiratory flow between 30-370 L/min.
Time frame: Baseline, Day 7 and Day 14
Change from baseline in Rhinoscopy score
Rhinoscopy score: during the nasal examination the investigator will evaluate the symptoms rhinorrhea, redness and edema using a 4-point scale as follows: absent = 0, mild = 1, moderate = 2, and severe = 3.
Time frame: Baseline, Day 7 and Day 14
Intra-group changes in health-related Quality of Life (RQLQ)
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). There are 3 'patient-specific' questions in the activity domain which allow patients to select 3 activities in which they are most limited by their rhinoconjunctivitis. Patients recall how bothered they have been by their rhinoconjunctivitis during the previous week and to respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains.
Time frame: Baseline, Day 7 and Day 14
Number of responders with an improvement of ≥ 0.5 points in the assessment of overall RQLQ
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). There are 3 'patient-specific' questions in the activity domain which allow patients to select 3 activities in which they are most limited by their rhinoconjunctivitis. Patients recall how bothered they have been by their rhinoconjunctivitis during the previous week and to respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains.
Time frame: Baseline, Day 7 and Day 14
Intra-group changes in the Rhinitis Control Assessment Test (RCAT) score
Rhinitis Control Assessment Test (RCAT) questionnaire has 6 items that include nasal congestion, sneezing, watery eyes, sleep problems caused by rhinitis, activity avoidance, and nasal or other allergy symptoms control. Responses are measured on a 5-point scales. RCAT scores range from 6 to 30, with higher scores indicating better rhinitis control.
Time frame: Baseline, Day 7 and Day 14
Number of responders with a RCAT score ≥22
Rhinitis Control Assessment Test (RCAT) questionnaire has 6 items that include nasal congestion, sneezing, watery eyes, sleep problems caused by rhinitis, activity avoidance, and nasal or other allergy symptoms control. Responses are measured on a 5-point scales. RCAT scores range from 6 to 30, with higher scores indicating better rhinitis control.
Time frame: Baseline, Day 7 and Day 14
Onset of action: Instantaneous TNSS
Instantaneous Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary.
Time frame: On Day 2 (first day of treatment) from 0 to 8 hours (at 5 minutes, 15 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h) after the first dose administration
Onset of action: instantaneous ocular symptoms
Instantaneous Ocular itching and Redness and Ocular tearing will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Time frame: On Day 2 (first day of treatment) from 0 to 8 hours (at 5 minutes, 15 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h) after the first dose administration