Seasonal allergic rhinitis MedDRA version: 20.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis System Organ Class: 100000004870
Conditions
Sponsors
Lek Pharmaceuticals d.d.
Eligibility
Sex/Gender
All
Inclusion criteria
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 - =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: 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.;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.;Timepoint(s) of evaluation of this end point: After closing the database and unbliniding the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 (?(baseline-treatment day 7), ?(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 (?(baseline-treatment day 7), ?(baseline-treatment day 14)); - Intra-group changes in the Rhinitis Control Assessment Test (RCAT) score in the course of treatment (?(baseline-treatment day 7), ?(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 (?(baseline-treatment day 7), ?(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 s | — |
Countries
Bulgaria, Germany, Moldova, Republic of, Poland
Contacts
Public ContactGroup Head Clinical Development
Lek Pharmaceuticals d.d.
Outcome results
None listed