Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma

Exclusion Criteria

• •1. Patients with hypersensitivity to any component of the study medications;
• •2. Patients with non-allergic rhinoconjunctivitis (e.g. vasomotor, infectious, drug-induced);
• •3. Presence of nasal polyps or any clinically important nasal anomaly;
• •4. History of acute and/or chronic sinusitis within 30 days of Visit 2;
• •5. History of eye surgery within 3 months of Visit 2;
• •6. History of intranasal surgery within 3 months of Visit 2;
• •7. Immunotherapy within 6 months prior to Visit 1;
• •8. Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 2;
• •9. Patients with moderate to severe renal impairment and taking P-gp inhibitors (e.g. ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem) within 7 days prior to the first dose of study medication;
• •10. Patients requiring daily "controller" medications with cromolyn-type drugs or leukotriene antagonists;
• •11. Patient required daily "controller" medication with Inhaled corticosteroids (ICS) or LABA at medium /high dosage defined by GINA criteria;
• •12. Patients with clinically important (based on principal investigator's judgment) hepatic impairment;
• •13. Patients with severe concomitant disease (based on principal investigator's judgment) that could interfere with treatment response;
• •14. Patients with QT syndrome;
• •15. Patients with Galactose intolerance, Lapp lactase deficiency or glucose- galactose malabsorption;
• •16. Pregnant or breast-feeding women;
• •17. Patients with a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study (based on principal investigator's judgment);
• •18. Patients who had a recent history (within previous 12 months) of drug addiction or alcohol abuse based on Principal investigator's judgment ;
• •19. Patients participating in or having participated in another clinical trial within the previous three months;
• •20. Patients unable to take relief medications due to contraindications or intolerance;
• •21. Patients who are taking or have taken any of the following medications prior to randomisation in the study and have not complied with the specified washout period:
• •* Antihistaminic drugs or montelukast (7 days)
• •* Systemic or intranasal corticosteroids (4 weeks)
• •* Delayed-release corticosteroids (3 months)
• •* Ketotifen (2 weeks)
• •* Macrolides antibiotics and imidazolic antifungals (systemic)(7 days)
• •* Anticholinergics (7 days)
• •* Drugs with antihistamine properties (phenothiazine) (7 days)
• •* Intranasal and systemic decongestants (3 days)
• •* Lodoxamide (7 days)
• •22. Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.
• •23. Patients who are planning to travel outside the study area during the course of the study.