A clinical trial to evaluate the safety and the efficacy of a combination of Rupatadine and Montelukast compared to Rupatadine in patients with Allergic Rhinitis

Phase 1

Conditions: Seasonal allergic rhinitis with and without mild to moderate bronchial asthma
MedDRA version: 21.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2020-005135-73-BG

Lead Sponsor: Biohorm, S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Written informed consent in accordance with applicable regulatory requirements.
2. Male and female outpatients aged 18 or more with at least 1-year history of SAR inadequately controlled and in need of alternative treatments as per the treating physicians with or without mild to moderate allergic bronchial asthma.
3. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use methods of contraception (barrier methods and oral contraceptives) throughout the study visits.
4. Positive skin prick test (wheal +/- 3 mm larger than the diluent control) to at least one seasonal allergen specific to their geographical location.
5. Evaluation of four nasal symptoms scores (T4NSS) measured as a reflective way (12 hours apart in the morning and evening periods) at screening.
6. Adequate wash-out to baseline if patients are taking any of the medications mentioned in table below. Nasal corticosteroids are the unique medication allowed in this period.
Additional inclusion criteria for patients with asthma
1. History of asthma for at least 6 months before screening.
2. Adult patients with mild-to-moderate asthma partially controlled by beclomethasone dipropionate =500 µg/d or equivalent according to GINA guidelines as shown in the table below (alone or in combination with long term ß2-adrenergic bronchodilators).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Active acute or chronic pulmonary disorder, acute sinus disease that have not resolved within 1 week (active hay fever and AR symptoms are allowed), and upper respiratory tract infection within 3 weeks, emergency department treatment of asthma within 1 month, and hospitalization for asthma within 3 months before the randomization visit.
2. Bronchial asthma patients who receive treatment with inhaled corticosteroids (ICS), alone or in combination with short and/or long term ß2-adrenergic bronchodilators, at dosage >500 µg beclomethasone dipropionate or equivalent (budesonide >400 µg/d, ciclesonide >160 µg/d, fluticasone >250 µg/d and mometasone >400 µg/d) within 2 weeks.
3. Daily treatment with montelukast within 7 days prior to randomization, cetirizine and bilastine (3 days), levocetirizine (2 days), loratadine, desloratadine, rupatadine and any other oral H1 antihistaminic not listed above (6 days), systemic corticosteroids (28 days), ketotifen (2 weeks), macrolides and imidazolic antifungals (7 days), anticholinergic drugs (7 days), topical antihistaminic drugs (e.g. nasal or drops) (2 days), drugs with antihistamine properties (e. g. phenothiazine) (6 days), intranasal/systemic decongestants and eye drops (3 days).
4. Patients suffering from non-allergic rhinitis (e.g., vasomotor, infectious, or drug-induced rhinitis).
5. Patients who had undergone nasal surgery in the previous 6 months and patients with nasal polyps, significant deviation of the nasal septum, acute or chronic sinusitis.
6. Clinically relevant respiratory tract malformations.
7. Recent nasal biopsy (within 2 months).
8. Nasal trauma; nasal surgery; atrophic rhinitis; rhinitis medicamentosa (within 2 months).
9. Antibiotic use for acute conditions within 2 weeks of screening.
10. History of QT prolongation and/or torsade de pointes, including congenital long QT syndromes, history of cardiac arrhythmias.
11. Smokers who report consuming more than 10 cigarettes per day.
12. History or presence of an immunodeficiency disorder.
13. Hypersensitivity to any beta-agonist, sympathomimetic drug, leukotriene antagonist.
14. Patients with a known history of HIV, hepatitis B or hepatitis C infection.
15. Any abnormal laboratory value of clinical relevance.
16. Pregnant or nursing mother.
17. Current evidence of any clinically significant disease of the hematopoietic, gastrointestinal, cardiovascular, pulmonary, or any other systems that might hinder the subject participation.
18. Abuse or dependency of alcohol, narcotics, opioids or any other addictive substances.
19. Patients that participated in any type of clinical study within the last month of the screening date.
20. Unsuitability for enrollment otherwise as decided by the investigator.
21. The drug products contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take these drugs.
22. Patients who had received immunotherapy for less than 6 months (unless on a stable dose within the prior month, and none within 24 hours before any study visit) or any Central Nervous System (CNS) acting agents (including antidepressants, sedatives, anxiolytics, hypnotics, opioids or neuroleptics) at any time.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate therapeutic superiority of the test FDC product (rupatadine and motelukast) over rupatadine monotherapy in seasonal allergic rhinitis patients with and without mild to moderate bronchial asthma inadequately controlled.;Secondary Objective: To assess efficacy and safety parameters of the fix dose combination and to collect additional data that supports superiority in terms of efficacy versus monotherapy with rupatadine;Primary end point(s): The main efficacy endpoint will be the change in the T4NSS on the 28 day of treatment (PDC reflective 12 hours symptoms, every day including the visit days with the investigator) compared with Day 0.<br>;Timepoint(s) of evaluation of this end point: End of treatment (day 28±2)<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Change in the total score of patient symptoms (T7SS) on the 28 day of treatment (reflective evaluation) compared with Day 0.<br>• Change in the total score of non-nasal patient symptoms (T3NNSS) on the 28 day of treatment (reflective evaluation) compared with Day 0.<br>• Change in the daily score for each symptom (DSS) on the 28 day of treatment (reflective evaluation) compared with Day 0.<br>• Mean value of the daily total score of symptoms (mTSS).<br>• Time to beginning of action (first week).<br>• Percentage of patients requiring rescue medication.<br>• Assessment of instantaneous overall effectiveness (both patient and investigator)<br>• Improvement in quality of life (Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ]) evaluated.;Timepoint(s) of evaluation of this end point: End of treatment (day 28±2)

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