CTRI/2025/05/086635尚未招募4 期
A Phase IV, open label, clinical trial to assess Safety and Efficacy of Fexofenadine HCl 60 mg plus Pseudoephedrine HCl 120 mg fixed dose combination in Indian participants with Allergic Rhinitis (AR) who are 12 years and above (FAST trial).
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 203
- 试验地点
- 11
- 主要终点
- To assess safety of Allegra® D (Fexofenadine HCL 60 + pseudoephedrine HCL 120 fixed dose combination)
研究概览
简要总结
This clinical trialis a phase 4, open label study to assess the safety & efficacy of a fixeddose combination i.e. Fexofenadine & pseudoephedrine in patientswith Allergic Rhinitis.
The study durationis expected to be of approx. 7-13 days, with 3 days follow up after end oftreatment.
The clinicalefficacy will be tested by the following parameters
a. TotalSymptom score
b. TotalNasal Symptom Score
Thesafety of the drug during the study will be monitored by adverse effectmonitoring during patient visits & Laboratory investigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 12.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant (male or female) must be 12 years or more
- •The participants who suffering from allergic rhinitis and are: a) Outpatients with diagnosis of AR confirmed with skin prick test on the day of screening (Evexia SPT kit) to out or indoor allergens [wheal greater than or equal to 3mm compared to control (diluent) b) Patient should have Nasal congestion score of 2 or more
- •The participant should be negative on COVID Rapid Antigen Test which is tested during the screening.
排除标准
- •Any clinically significant abnormality identified either in medical history or during screening evaluation (e.g., physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period, which in judgment of the investigator would preclude safe completion of the study or constrains efficacy assessment.
- •History of narrow-angle glaucoma or urinary retention or seizures
- •Patients who have severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures.
- •Patients having renal/hepatic insufficiency
- •Patients with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, acute rhinitis, deviation of the nasal septum, etc.), upper respiratory tract infection or acute otitis media that could interfere with judgment of the efficacy of the investigational product (IP)and patients developing cold-like symptoms 30 days before the screening visit .
- •Patients using following drugs A.
- •within 5 days prior to the day of screening: a) Intranasal or oral: antiallergic drugs, decongestants, antihistamines, anticholinergic agents, vasoconstrictor, antihistamine-containing cold remedies, agents that can be expected to have an antiallergic/antihistaminic effect , and other agents that are indicated for allergic symptoms (sneezing, rhinorrhea, nasal congestion, etc.) b) agents that may affect the blood concentration of fexofenadine (macrolide antibiotics, azole fungicides, and preparations containing aluminum hydroxide / magnesium hydroxide) B.
- •within 2 weeks prior to screening visit a)patients using steroids, sodium cromoglycate/nedocromil or leukotriene modifiers b)patients receiving monoamine oxidase (MAO) inhibitor therapy c)patients receiving immunotherapy or immunosuppressants or nonspecific alternative therapy (histamine containing gamma globulin preparations etc)
- •Patients who are participating in another study or who have previously participated in another study within the previous 3 months prior to the day of screening
- •Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
- •Participant not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- •Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6)
- •Any specific situation during study implementation/course that may raise ethics considerations
- •Patients were excluded from the study if they had a known or suspected history of alcoholism or drug abuse;
- •Patients were excluded from the study if they had hypersensitivity to, fexofenadine HCl, or pseudoephedrine HCl;
- •Participants who withdraw consent during the screening (starting from signed ICF).
结局指标
主要结局
To assess safety of Allegra® D (Fexofenadine HCL 60 + pseudoephedrine HCL 120 fixed dose combination)
时间窗: 2 week (Approx 16 days)
次要结局
- To evaluate efficacy of Allegra® D (Fexofenadine 60 + pseudoephedrine 120 combination) measured as per change in Total symptom score (TSS) and Nasal congestion score (NCS) as assessed by doctor(2 week (Approx 16 days))
研究者
研究点 (11)
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