Clinical Trials/NCT05311475

NCT05311475

Completed

Phase 3

A Multicenter, Randomized, Double-blind, Placebo and Active Controlled Parallel-group Trial to Assess the Efficacy and Safety of the Fixed Combination Medicinal Product Mometasone Furoate + Azelastine Hydrochloride Nasal Spray (50 + 140 mcg) in the Treatment of Seasonal Allergic Rhinitis

Sandoz1 site in 1 country669 target enrollmentApril 4, 2022

ConditionsSeasonal Allergic Rhinitis

InterventionsMometasone Azelastine Placebo

DrugsMometasone Azelastine Placebo

Overview

Phase: Phase 3
Intervention: Mometasone
Conditions: Seasonal Allergic Rhinitis
Sponsor: Sandoz
Enrollment: 669
Locations: 1
Primary Endpoint: Change from baseline in the daily Total Nasal Symptom Score (TNSS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 4, 2022

End Date

June 20, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sandoz

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Only patients fulfilling all of the following criteria at screening Visit 1 should be included in the present trial:
•Male or non-pregnant, non-lactating female patient aged between 12 and 65 years (valid for Poland) OR between 18 and 65 years (valid for Bulgaria, Moldova and Germany) inclusive on the date of consent.
•Female patient of childbearing potential abstaining from sexual intercourse or using a reliable method of contraception (e.g., condom with spermicide, intra uterine device, oral, injected, transdermal or implanted hormonal contraceptives, or had in the past a female sterilization e.g. tubal ligation, hysterectomy, oophorectomy, salpingectomy) for 30 days before enrolment and agree to continue its use during the trial.
•A minimum of two seasons of previous history of at least moderate seasonal allergic rhinitis (SAR) to the pollen/allergens in season at the time the trial is being conducted.
•Patient must have the following SAR symptoms: (i) nasal congestion, and at least one of the following; (ii) rhinorrhea; (iii) nasal itching; or (iv) sneezing. Nasal congestion plus one other nasal symptom score both rated by the patient as at least moderate in severity (≥2 on a 0-3 scale) and Total Nasal Symptom Score (TNSS) ≥6.0 over the last 24 hours.
•Negative SARS-CoV-2 Rapid Antigen Test result at screening visit.
•For adults (≥18 years): Informed consent to participate in the trial provided in written form; For adolescents (≥12 - \<18 years): own patient informed consent/ assent to participate in the trial and the informed consent from all parent(s)/ legal guardian(s) provided in written form.
•Inclusion criteria at Visit 2 (selection for randomization):
•Only patients fulfilling at Visit 2 the following inclusion criteria will be randomized in the trial:
•Pollen-specific immunoglobulin E (sIgE) test ≥EAST class 3 (at least 3.5 kU/l).

Exclusion Criteria

•Patients presenting any of the following criteria will NOT be included in the trial:
•Simultaneous participation in other clinical trials.
•Use of any investigational drug within 30 days prior to enrolment (Visit 1).
•Clinically significant medical condition (such as cardiovascular, hepatic, neurological, hematological, renal, gastrointestinal, endocrine or other major systemic disease) that, in the judgement of the investigator, would interfere with the trial, require treatment, or make implementation of the protocol or interpretation of the trial results difficult.
•Any known hypersensitivity to azelastine or other antihistamines, mometasone or other steroids, or any of the components of the trial nasal sprays.
•Structural nasal abnormalities symptomatic enough to cause nasal obstruction, as judged by the investigator, or any recent nasal surgery or trauma that is not completely healed.
•Any other nasal conditions, including infectious rhinitis, sinusitis, rhinitis medicamentosa, atrophic rhinitis, and perennial rhinitis (PAR) (coexisting PAR will be allowed if SAR shows clear exacerbations).
•History of upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to screening.
•Treatment for oral candidiasis within 30 days of starting the trial.
•Presence of untreated fungal, bacterial or viral systemic infection, or infection of the ear, nose, and throat or oral cavity of any character.

Arms & Interventions

Mometasone + Azelastine

Mometasone + Azelastine (50 + 140 mcg per actuation)

Intervention: Mometasone

Mometasone + Azelastine

Mometasone + Azelastine (50 + 140 mcg per actuation)

Intervention: Azelastine

Mometasone

Mometasone furoate nasal spray (50 mcg per actuation)

Intervention: Mometasone

Azelastine

Azelastine hydrochloride nasal spray (140 mcg per actuation)

Intervention: Azelastine

Placebo

Placebo nasal spray

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline in the daily Total Nasal Symptom Score (TNSS)

Time Frame: Baseline, Day 7

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.

Secondary Outcomes

Baseline-adjusted differences in nasal obstruction assessed by peak nasal inspiratory flow measurements (PNIF)(Baseline, Day 7 and Day 14)
Number of responders with an improvement of ≥ 0.5 points in the assessment of overall RQLQ(Baseline, Day 7 and Day 14)
Change from baseline in individual daily ocular symptoms(Baseline, Day 7 and Day 14)
Change from baseline in Rhinoscopy score(Baseline, Day 7 and Day 14)
Change from baseline in the daily Total Nasal Symptom Score (TNSS)(Baseline, Day 14)
Intra-group changes in health-related Quality of Life (RQLQ)(Baseline, Day 7 and Day 14)
Change from baseline in individual daily nasal symptoms(Baseline, Day 7 and Day 14)
Intra-group changes in the Rhinitis Control Assessment Test (RCAT) score(Baseline, Day 7 and Day 14)
Number of responders with a RCAT score ≥22(Baseline, Day 7 and Day 14)
Onset of action: Instantaneous TNSS(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(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)