Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis

NCT05311475 | Completed Phase 3

• 2 other identifiers: CLK21001/SAN-06772021-004050-31
• Study Type: interventional
• Target: 669
• Locations: 4 countries
• Sites: 28

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Day 7

Secondary Outcomes (11)

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

  Baseline, Day 14

• Change from baseline in individual daily nasal symptoms

  Baseline, Day 7 and Day 14

• Change from baseline in individual daily ocular symptoms

  Baseline, Day 7 and Day 14

• Baseline-adjusted differences in nasal obstruction assessed by peak nasal inspiratory flow measurements (PNIF)

  Baseline, Day 7 and Day 14

• Change from baseline in Rhinoscopy score

  Baseline, Day 7 and Day 14

Study Arms (4)

Mometasone + Azelastine

EXPERIMENTAL

Mometasone + Azelastine (50 + 140 mcg per actuation)

Drug: Mometasone; Drug: Azelastine

Mometasone

ACTIVE COMPARATOR

Mometasone furoate nasal spray (50 mcg per actuation)

Drug: Mometasone

Azelastine

ACTIVE COMPARATOR

Azelastine hydrochloride nasal spray (140 mcg per actuation)

Drug: Azelastine

Placebo

PLACEBO COMPARATOR

Placebo nasal spray

Drug: Placebo

Interventions

Mometasone DRUG

Mometasone furoate nasal spray (50 mcg per actuation)

Mometasone; Mometasone + Azelastine

Azelastine DRUG

Azelastine hydrochloride nasal spray (140 mcg per actuation)

Azelastine; Mometasone + Azelastine

Placebo DRUG

Placebo nasal spray

Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Pollen-specific immunoglobulin E (sIgE) test ≥EAST class 3 (at least 3.5 kU/l).
• Negative serum (hCG) pregnancy test (for female patient only).
• Patient selected for randomization must have the following SAR symptoms over 3 days during the 3- to 5-day baseline period: (i) nasal congestion, and 1 or more of the following; (ii) rhinorrhea; (iii) nasal itching; or (iv) sneezing.
• The mean TNSS must be ≥6.0 over 3 days out of the last 3-5 days of the Placebo run-in period; additionally, the mean nasal congestion score and mean of 1 other nasal symptom score both must be ≥2 (on a 0-3 scale) over 3 days out of the last 3-5 days of the Placebo run-in period.

You may not qualify if:

• 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.
• Presence of ocular herpes simplex or cataracts, or a history of glaucoma.
• Vaccination within 14 days prior to screening visit.
• History of habitual abuse of nasal decongestants (rhinitis medicamentosa).
• History of non-response to intranasal steroids.
• History of non-response to antihistamines.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (28)

Sandoz Investigative Site

Burgas, Bulgaria

Location

Sandoz Investigative Site

Gabrovo, Bulgaria

Location

Sandoz Investigative Site

Plovdiv, Bulgaria

Location

Sandoz Investigative Site

Sliven, Bulgaria

Location

Sandoz Investigative Site

Sofia, 1606, Bulgaria

Location

Sandoz Investigative Site

Sofia, Bulgaria

Location

Sandoz Investigative Site

Varna, Bulgaria

Location

Sandoz Investigative Site

Aachen, Germany

Location

Sandoz Investigative Site

Dreieich, Germany

Location

Sandoz Investigative Site

Dresden, Germany

Location

Sandoz Investigative Site

Duisburg, Germany

Location

Sandoz Investigative Site

Hamburg, Germany

Location

Sandoz Investigative Site

Heidelberg, Germany

Location

Sandoz Investigative Site

Neuenhagen, Germany

Location

Sandoz Investigative Site

Röthenbach, Germany

Location

Sandoz Investigative Site

Schorndorf, Germany

Location

Sandoz Investigative Site

Viernheim, Germany

Location

Sandoz Investigative Site

Chisinau, Moldova

Location

Sandoz Investigative Site

Brzeg Dolny, Poland

Location

Sandoz Investigative Site

Chodzież, Poland

Location

Sandoz Investigative Site

Inowrocław, Poland

Location

Sandoz Investigative Site

Jaksice, Poland

Location

Sandoz Investigative Site

Lodz, Poland

Location

Sandoz Investigative Site

Lublin, Poland

Location

Sandoz Investigative Site

Ostrowiec, Poland

Location

Sandoz Investigative Site

Poznan, Poland

Location

Sandoz Investigative Site

Warsaw, Poland

Location

Sandoz Investigative Site

Wroclaw, Poland

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Mometasone Furoate; azelastine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: March 25, 2022
• First Posted: April 5, 2022
• Study Start: April 4, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

MO (1); PL (10); BU (7); DE (10)