Moderate to severe seasonal allergic rhinitis with and without mild to moderate bronchial asthma MedDRA version: 21.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855
Conditions
Sponsors
Biohorm, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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 [including a variety of common grass pollens (bermuda, rye, sweet grass, blue grass, perennial rye, and timothy grass) and tree pollens (birch, Cupressus spp., oak, olive, Platanus spp., beech, alder, hazelnut, white ash and Salix spp.)]. Patients with allergens for perennial allergic rhinitis can also be included if they are asymptomatic with test positive to seasonal pollen allergens specific to their geographical location. 5. Clinically symptomatic at screening after washout with a total score of > or = 48 (out of 72) as the sum of the reflective nasal symptoms score (T4NSS) measured twice a day (12 hours apart in the morning and the evening of the same day) in 3 non-consecutive days of the last 7 days of the screening period. 6. Adequate wash-out to baseline if patients are taking any of the some medications. 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 or equivalent =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 ICS, alone or in combination with short and/or long term ß2-adrenergic bronchodilators, at dosage >500 µg beclomethasone dipropionate or equivalent within 2 weeks. 3. Daily treatment with antihistaminic drugs or montelukast within 7 days prior to randomization, systemic corticosteroids (4 weeks), ketotifen (2 weeks), macrolides and imidazolic antifungals (7 days), anticholinergic drugs (7 days), drugs with antihistamine properties (e. g. phenothiazine) (7 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. Smoking history of more than 5 pack-years or more, including electronic smoking history. 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 h before any study visit) or any CNS acting agents (including antidepressants, sedatives, anxiolytics, hypnotics, opioids or neuroleptics) at any time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate therapeutic superiority of the test FDC product (rupatadine and motelukast) over rupatadine monotherapy in moderate to severe 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. ;Timepoint(s) of evaluation of this end point: End of treatment (day 28) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. • Change in the total score of non-nasal patient symptoms (T3NNSS) on the 28 day of treatment (reflective evaluation) compared with Day 0. • Change in the daily score for each symptom (DSS) on the 28 day of treatment (reflective evaluation) compared with Day 0. • Mean value of the daily total score of symptoms (mTSS). • Time to beginning of action (first week). • Percentage of patients requiring rescue medication. • Assessment of instantaneous overall effectiveness (both patient and investigator) • 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) | — |
Countries
Bulgaria, Poland, Spain
Contacts
Public ContactDaniel Peris
Biohorm, S.L.
Outcome results
None listed