ACTRN12606000348550招募中3 期
Active-Controlled Trial of the Safety and Tolerability of MP03-33 (Nasal Spray) in Patients with Chronic Allergic or Nonallergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Years 至 ot stated（—）
- 性别
- All
入选标准
- •a. An established history (> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR). Patients with a seasonal allergic component may also be included, provided that they have had significant symptoms outside the allergy seasons. b. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent.c. Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome.d. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor’s medical officer.e. Patients receiving immunotherapy (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit adjustments to regimen following a brief period of missed injections does not preclude participation).
排除标准
- •a. The use of any investigational drug within 30 days prior to screening. No other investigational products are permitted for use during the conduct of this study.b. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)c. Women who are pregnant or nursing.d. Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. e. Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.f. Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease.g. Patients with a known history of alcohol or drug abuse.h. Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study.i. Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures.j. Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol.
研究者
相似试验
进行中（未招募）
不适用
Study assessing safety and tolerability of a nasal spray combination of azelastine and fluticasone in patients with chronic rhinitistreatment of chronic allergic or non-allergic rhinitisMedDRA version: 13.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 13.1Level: LLTClassification code 10034383Term: Perennial rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-001368-23-Outside-EU/EEAMedPointe Pharmaceuticals600
进行中（未招募）
1 期
Active-Controlled Trial of the Safety and Tolerability of MP03-33 in Patients with Chronic Allergic or Nonallergic Rhinitis - NAEUCTR2006-001510-32-SKMedPointe Pharmaceuticals800
尚未招募
1 期
Study Aimed at Assessing whether the Vaccine is safe, how much the body tolerates and how much the immune system reacts to the LEP-F1 + GLA-SE Vaccine in adult participants in a region where there are many patients with leprosyeprosyTuberculoid leprosyBorderline tuberculoid leprosyLeprosy sequelae (leprosy)RBR-88jm8ykInstituto de Tecnologia em Imunobiológicos Bio-Manguinhos / Fiocruz
进行中（未招募）
不适用
Study in healthy subjects and type 2 diabetic subjects to assess the safety, tolerability and pharmacokinetics of 28 days EV-077-3201-2TBS treatment, and the effects of thromboxane receptor antagonism on platelet function, vascular inflammation and vascular oxidative stressHealthy subjects and subjects with Type 2 DiabetesMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-003808-20-DEEvolva SA96
进行中（未招募）
不适用
Preliminary Study to Evaluate the Safety and Tolerability of the combination ot Trabectidin and Indole-3-Carbinol in advanced breast cancer hormonal receptor positive who failed previous chemioterapy treatmentRefractory ER-positive metastatic breast cancerMedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001288-32-ITFONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE