CTRI/2017/12/011000进行中（未招募）3 期
A Prospective, Multi-Centric, Double Blind, Parallel Group, Active ControlledRandomized Study to Evaluate the Efficacy and Safety of Bilastine in Adult andAdolescent Patients with Seasonal Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
排除标准
- •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
研究者
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