| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Seasonal allergic rhinitis |
|
| E.1.1.1 | Medical condition in easily understood language |
| Seasonal allergic rhinitis |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10039776 |
| E.1.2 | Term | Seasonal allergic rhinitis |
| E.1.2 | System Organ Class | 100000004870 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The primary objective of the present trial is to show the benefit of the treatment on nasal symptoms in patients with seasonal allergic rhinitis with the fixed combination medicinal product (test; MomAze nasal spray) Mometasone + Azelastine nasal spray (50 mcg / 140 mcg per actuation) in comparison to the treatment with the individual medicinal products Mometasone furoate nasal spray (50 mcg per actuation) and Azelastine hydrochloride nasal spray (140 mcg per actuation) (comparators; Mometasone, Azelastine). |
|
| E.2.2 | Secondary objectives of the trial |
To compare MomAze nasal spray and comparators with Placebo nasal spray.
To assess (as exploratory endpoints) the impact of the test product and the comparators on the individual nasal symptoms, health-related quality of life, ocular symptoms, Peak Nasal Inspiratory Flow (PNIF), rhinoscopy score, Rhinitis Control Assessment Test (RCAT), instantaneous TNSS (iTNSS) and instantaneous ocular symptoms. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
[1] 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, Germany, Moldova) inclusive on the date of consent.
[2] Female patient of childbearing potential using highly effective contraception methods such as: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence; permanent sterilization methods e.g. hysterectomy, bilateral salpingectomy and bilateral oophorectomy for 30 days before enrolment and agree to continue its use during the trial and for a period of 14 days after the last dose.
[3] 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.
[4] 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.
[5] Negative SARS-CoV-2 Rapid Antigen Test result at screening visit.
[6] For adults (≥18 years): Informed consent to participate in the trial provided in written form;
For adolescents (≥12 - <18 years - valid for Poland): 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.
[7] Pollen-specific immunoglobulin E (sIgE) test ≥EAST class 3 (at least 3.5 kU/l).
[8] Negative serum (hCG) pregnancy test (for female patient only).
[9] 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. |
|
| E.4 | Principal exclusion criteria |
[1] Simultaneous participation in other clinical trials.
[2] Use of any investigational drug within 30 days prior to enrolment (Visit 1).
[3] 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.
[4] Any known hypersensitivity to azelastine or other antihistamines, mometasone or other steroids, or any of the components of the trial nasal sprays.
[5] Structural nasal abnormalities symptomatic enough to cause nasal obstruction, or any recent nasal surgery or trauma that is not completely healed, or presence of chronic paranasal sinus disease with polyps confirmed by an otolaryngologist.
[6] 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).
[7] History of upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to screening.
[8] Treatment for oral candidiasis within 30 days of starting the trial.
[9] Presence of untreated fungal, bacterial or viral systemic infection, or infection of the ear, nose, and throat or oral cavity of any character.
[10] Presence of ocular herpes simplex or cataracts, or a history of glaucoma.
[11] Vaccination within 14 days prior to screening visit.
[12] History of habitual abuse of nasal decongestants (rhinitis medicamentosa).
[13] History of non-response to intranasal steroids.
[14] History of non-response to antihistamines.
[15] Recent exposure or being at risk to chicken pox or measles exposure.
[16] The patient is receiving immunotherapy or has received immunotherapy in the last 24 months.
[17] Use of anti-immunoglobulin E antibodies within 6 months prior to screening visit.
[18] Use of any of the following drugs:
a. Systemic corticosteroid therapy within 60 days prior to screening visit.
b. Topical (intranasal, inhaled, ocular) corticosteroid therapy within 30 days prior to screening visit.
c. Immunosuppressive drugs and immunomodulating drugs within 30 days prior to screening visit.
d. Cromolyn sodium or nedocromil within 14 days prior to screening visit.
e. Tricyclic antidepressants within 14 days prior to screening visit.
f. Histamine H1 antagonists (any generation of antihistamines) i.e., loratadine, cetirizine, desloratadine, levocetirizine, fexofenadine, hydroxyzine, etc. within 14 days prior to screening visit.
g. Leukotriene modifiers within 7 days prior to screening visit.
h. Nasal or oral decongestants (including anticholinergic agents, oxymetazoline, ephedrine or pseudoephedrine, and other vasoconstrictors) and mucolytics (like guaifenesin), or other medications that could mask the symptoms of rhinitis, e.g., major tranquilizers, anti-epileptic agents, within 3 days prior to screening visit. This includes over-the-counter preparations for common cold or eye drops containing any of the above-mentioned agents.
i. Nasal sprays or washes with any medication, including saline, within 24 hours prior to screening visit.
[19] Planned to travel outside of the geographical region (as judged by the investigator according to regional pollination calendar) for >3 consecutive days during the trial.
[20] Member of the investigational trial staff or a member of the family of the investigational trial staff.
[21] History of alcohol or drug abuse within the last 5 years.
[22] History of non-compliance with medication regimens or treatment protocols in previous clinical studies.
[23] Legal incapacity (for adults only) and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial.
[24] Patients who are known or suspected to be in custody or submitted to an institution due to a judicial order. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The benefit of the treatment with the fixed combination medicinal product MomAze 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. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| After closing the database and unbliniding the trial |
|
| E.5.2 | Secondary end point(s) |
- Graphs to display the mean change from baseline in TNSS over the 14-day treatment period for all four arms;
- Change from baseline in the daily TNSS during first 3 and 14 days of treatment for all four arms;
- 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;
- Change from baseline in individual daily ocular symptoms for all four arms;
- The baseline-adjusted differences in nasal obstruction assessed by peak nasal inspiratory flow measurements (PNIF) after 7 and 14 days of treatment for all four arms;
- The change from baseline in Rhinoscopy score after 7 and 14 days of treatment for all four arms;
- Intra-group changes in health-related Quality of Life (RQLQ) in the course of treatment (Δ(baseline-treatment day 7), Δ(baseline-treatment day 14));
- Inter-group differences in health-related Quality of Life (RQLQ) at baseline, at treatment day 7 and at treatment day 14;
- The proportion of patients (responder) with an improvement of ≥ 0.5 points in the assessment of overall RQLQ in the course of treatment (Δ(baseline-treatment day 7), Δ(baseline-treatment day 14));
- Intra-group changes in the Rhinitis Control Assessment Test (RCAT) score in the course of treatment (Δ(baseline-treatment day 7), Δ(baseline-treatment day 14));
- The comparison of the inter-group differences in RCAT score at baseline, at treatment day 7 and at treatment day 14;
- The proportion of patients (responder) with a RCAT score ≥22 in the course of treatment (Δ(baseline-treatment day 7), Δ(baseline-treatment day 14))
- Onset of action: Instantaneous TNSS on day 2 from 0 to 8 hours after the first dose administration
- Onset of action: instantaneous ocular symptoms on day 2 from 0 to 8 hours after the first dose administration.
- Change from baseline in the number of symptom-free days;
- Use of concomitant medication (rescue medication) to control SAR symptoms in addition to the study medication;
- Assessment of patient’s treatment acceptability by means of a questionnaire at or after the end of treatment. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| After closing the database and unbliniding the trial |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 36 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| LVLS is Visit 4 on study Day 16 (+1) |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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