Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.

NCT05590598 | Completed Phase 3

• 1 other identifier: SAN-0727
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 15

Brief Summary

Prospective, multicenter, open, randomized, parallel, clinical study for assessment of comparative efficacy and safety of Azelastine +Mometasone Sandoz (main group) and Momat Rino Advance (control group) administered as a monotherapy to patients with seasonal allergic rhinitis (SAR).

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean total score change as per scale r-TNSS (AM/PM) with initial total score

  r-TNSS (reflective Total Nasal Symptom Score) consists of 4 symptom scores (Nasal congestion, Runny nose, Itchy nose, Sneezing), each of which can be scored on a 4-point scale (0-3). Higher scores mean a more severe symptom. By its nature, the total index r-TNSS is a rank indicator, it is an integer from the range from 0 to 12 points. As a working indicator, the average between the morning and evening values is used. As a measure of the effect of the drug, the change in the index relative to the initial value is used. Baseline is defined as the average r-TNSS score over three days of the Run-in period (2 morning (AM) and 3 evening (PM)) plus morning measurements of study day 1 (assessment in the morning prior to first administration).

  Day 1, 7 and 15 post treatment

Secondary Outcomes (6)

• Mean total score change as per scale i-TNSS (AM/PM) with initial total score

  Day 1, 7 and 15 post treatment

• Mean change in total score as per scales i-TNSS and r-TNSS with initial total score

  Day 1, 7 and 15 post treatment

• Change in Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S))

  Day 1, 7 and 15 post treatment

• Number of Adverse events

  throughout the study, approximately 18 days

• Proportion of patients with at least one adverse event

  throughout the study, approximately 18 days

Study Arms (2)

Group 1: Azelastine + Mometasone, nasal spray

EXPERIMENTAL

Participants will receive test product Azelastine + Mometasone, nasal spray, 140 mcg + 50 mcg/dose (Sandoz d.d., Slovenia), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days.

Combination Product: Azelastine + Mometazone, nasal spray

Group 2: Momat Rhino Advance, nasal dosed spray

ACTIVE COMPARATOR

Participants will receive reference product Momat Rhino Advance, nasal dosed spray, 140 mcg + 50 mcg mcg/dose (Glenmark Pharmaceuticals Limited., India), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days.

Combination Product: Momat Rhino Advance

Interventions

Azelastine + Mometazone, nasal spray COMBINATION_PRODUCT

140 mcg + 50 mcg/dose (Sandoz d.d., Slovenia), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days.

Group 1: Azelastine + Mometasone, nasal spray

Momat Rhino Advance COMBINATION_PRODUCT

140 µg + 50 µg/dose - one actuation into each nostril twice daily - morning and evening (interval between administrations is 12 hrs), corresponding to 560 µg/day of azelastine and 200 µg/day of mometasone for 14 consecutive days

Group 2: Momat Rhino Advance, nasal dosed spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting the following criteria will be included in the study and allocated to treatment groups:
• to 65 years old inclusive, male and female;
• voluntarily signed informed consent for participation in this clinical study;
• presence of confirmed moderate or severe seasonal allergic rhinitis occurring during pollen/allergen season of at least 24 months prior to enrollment in the study;
• presence of nasal symptoms of SAR (nasal congestion, rhinorrhea, nasal itching, sneezing): total score as per scale of reflective Total Nasal Symptoms Score (r-TNSS) at least 6: wherein, nasal congestion - at least 2 scores, as well as at least 2 scores in assessment of at least one of other three symptoms at Screening Visit and Visit 2;
• presence of documented positive result for dermic allergy test and/or serology allergen-specific IgE test performed for one or more allergens 12 months or earlier prior to enrollment to this study (patients should have positive skin tests and/or serology allergen-specific IgE test at least with one allergen, specific to the season during which clinical trial is conducted);
• fertile females shall have negative pregnancy test at screening (except for the women after surgical sterilization or with 2 year and more period of menopause);
• for women of child-bearing potential - consent to use one of following methods of effective contraception for the duration of study, as well for 30 days after the study end: Total abstinence. Oral contraceptives (combination medications containing progestagen or only progestagen).
• Injection progestogen. Implants with levonorgestrel. Estrogen containing vaginal ring. Skin patch with contraceptive. Intrauterine device (IUD) or intrauterine system (IUS) that complies with efficacy criteria as stated in PIL.
• Male partner is sterile (vasectomy with documented azoospermia) prior to female enrollment into the study based on condition that this partner is the only partner for this patient. For this definition "documented" is related to the result of medical examination by Investigator/Patient's Responsible Party or medical history review for assessment of enrollment to the study received orally by the patient or from medical record of the patient.
• Double barrier method: condom or occlusive cap (diaphragm or cervical/camerated cap) plus spermicide (foam/gel/film/cream/suppository);
• for male subjects: consent to follow with the female partner adequate contraception method for the duration of participation in the study from beginning to the end, as well as for 30 days after the end of the study;
• absence of somatic diseases of unstable severe character or in the phase of decompensation;
• ability to understand information about clinical study, readiness to follow requirements of study protocol, ability to use dosed nasal spray individually and assess symptoms of seasonal allergic rhinitis with the help of rating scale.
• Patients related to any of the following groups will not be included in the study:

You may not qualify if:

• The subject's participation will be terminated if any of the following causes occurs:
• The occurrence of any disease or condition during the study that worsens the patient's prognosis and makes it impossible for the patient to participate further in the clinical trial.
• The need to prescribe prohibited concomitant therapy.
• A positive PCR test for SARS-CoV-2.
• Pregnancy of the patient.
• Patient's refusal to participate in the study.
• Other administrative reasons

Sponsors & Collaborators

• Sandoz: lead

Study Sites (15)

Sandoz Investigative Site

Chelyabinsk, 454048, Russia

Location

Sandoz Investigative Site

Khasavyurt, 368006, Russia

Location

Sandoz Investigative Site

Krasnodar, 350012, Russia

Location

Sandoz Investigative Site

Nal'chik, 360002, Russia

Location

Sandoz Investigative Site

Pyatigorsk, 357501, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 194156, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 194354, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 196158, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 197342, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 197706, Russia

Location

Sandoz Investigative Site

Saratov, 410054, Russia

Location

Sandoz Investigative Site

Stavropol, 355000, Russia

Location

Sandoz Investigative Site

Vladikavkaz, 362027, Russia

Location

Sandoz Investigative Site

Volgograd, 400005, Russia

Location

Sandoz Investigative Site

Yaroslavl, 150040, Russia

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

azelastine; Nasal Sprays

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sandoz

  Sandoz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: February 13, 2023
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

RU (15)