Health Condition 1: null- Adult and Adolescent Patients with Seasonal Allergic Rhinitis Health Condition 2: J302- Other seasonal allergic rhinitis
Conditions
Interventions
Intervention1: Bilastine tablets 20mg: Bilastine tablets (20mg) administered 1 hour before meals or 2 hours after taking meals
Dosage: Orally, Once daily for 14 days
Control Intervention1: Cetirizine
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult and Adolescent male or female patients with age of 12 to 60 years and willing to give written, signed, and dated informed consent to participate in the study (In case of a minor 12 to 18 years, consent from parent/legally authorized representative (LAR) must also to be obtained in addition to the assent from the patient) 2. Patients with documented and/or clinical history of Seasonal Allergic Rhinitis (SAR), for at least 1 year prior to the study inclusion 3. Positive skin prick test or intradermal test for at least one of the seasonal allergen specific of the geographical area. A previous positive Prick test, or a positive IgE Test (RAST) may also be accepted, if performed within 12 months prior to the inclusion of the study. 4. Patients with moderate to moderately severe baseline 12-hour nasal symptom score (NSS; for rhinorrhea, congestion, itching and sneezing) of > 36 out of a possible total score of 72, assessed on the last 3 days during the screening period assessed on the day of randomization. 5. Patients willing to attend the required visits scheduled in the protocol, and filling the diary card provided 6. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study 7. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator
Exclusion criteria
Exclusion criteria: 1. Patients who have non-allergic rhinitis (vasomotor, infectious, druginduced) 2. Patients who had undergone nasal surgery within the previous 6 months. 3. Patients with nasal polyps, significant deviation of the nasal septum or significant nasal tract structural malformation 4. Patients with acute or chronic sinusitis, asthma (requiring regular use of inhaled or systemic corticosteroids) or any other condition that can interfere with the aim of the study. 5. Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent topical corticosteroids or use of leukotriene modifiers or long-acting antihistamines or macrolide antibiotics, imidazole antifungals, anticholinergics, or drugs with antihistaminic properties such as phenothiazine 6. Patients who had received immunotherapy in last 2 years (unless on a stable dose within the prior month, and none within 24 h before any study visit). 7. Patients on CNS acting drugs (including antidepressants, sedatives, anxiolytics, hypnotics, opioids or neuroleptics) at any time of the study that would affect assessment of the effectiveness of the study drug 8. Patients with moderate or severe renal impairment, co-administration of study drug with P-gp inhibitors eg, ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem 9. Previous intolerance or hypersensitivity to study drugs or any antihistamines, imidazoles, lactose or to any piperazine derivatives. 10. Patients planning to travel outside of the study area during the course of the study 11. Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession 12. Psychiatric disorder that interferes with the patients ability to comply with the study protocol 13. Patients with a history of alcohol and drug abuse and those with any clinically any significant condition [cardiovascular (electrocardiographic abnormalities, arrhythmia, recent acute myocardial infarction), neurological, hepatic, renal or malignant diseases] as assessed by the investigator. 14. Patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) and epileptic patients or patients at risk of convulsions 15. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption 16. Planned surgery or hospitalization during the trial 17. Pregnant or nursing women and positive pregnancy test in nonmenopausal women during the study. 18. Patients with HIV infection, chronic hepatitis B, or hepatitis C Infection 19. Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient 20. Receipt of any investigational drug within the previous 3 months of Screening Visit 21. Inability to cooperate with study personnel or history of noncompliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean area under the curve (AUC) of the total symptoms score (TSS) from day 0 (D0) to day 14 (D14) based on the patients evaluation of symptom severity over the past 12 h.Timepoint: Day 0 to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigators global clinical impression (CGI) at D7 and D14Timepoint: Day 7 and Day 14;Mean change in individual symptom scores from baseline to D7 and D14 based on the patient’s evaluation of symptom severity over the past 12 hTimepoint: Day 0, Day 7 and Day 14;Mean change in NSS and NNSS from baseline to D7 and D14 based on the patient’s evaluation of symptom severity over the past 12 h.Timepoint: Day 0, Day 7 and Day 14;Mean change in Overall assessment of discomfort due to Allergic rhinitis from D0 to D7 and D14 based on the Visual Analogue Scale (VAS) assessed by patient.Timepoint: Day 0, Day 7 and Day 14;Mean change in TSS from baseline to D7 and D14 based on the patient’s evaluation of symptom severity over the past 12 h.Timepoint: Day 0, Day 7 and Day 14;Quality of Life (QoL) assessment by Rhinitis and Rhinoconjuctivitis Quality of Life Questionnaire (RQLQ) at D0 and D14Timepoint: Day 0 and Day 14;Treatment emergent clinical & laboratory adverse events (TEAEs)Timepoint: All visits | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha MD
Hetero Labs Limited
Outcome results
None listed