CTRI/2021/05/033508已完成4 期
Prospective, multi-center, open-label, single-arm, clinical study to evaluate safety and efficacy of OmaliRel™ in patients with moderate to severe persistent asthma.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
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
- •Patient with the diagnosis of moderate to severe persistent asthma >1 year duration
- •and who have the history of the following :
- •- Patients with a positive prick skin test to at least one perennial allergen (e.g.
- •dust mite, animal dander, cockroaches), within the past 1 year or at
- •- Patients with total serum IgE level 76 to 700 IU/ml.
- •- Patients demonstrating 12% increase in FEV1 and 200mL of absolute value
- •of FEV1 over baseline value within 20-30 minutes of taking up to 4 puffs of
- •Short-Acting Beta Agonists (SABA) documented within the past year or at
- •screening or at baseline prior to dosing.
- •- Patients with FEV1 < 80% of predicted normal value for the patient
- •(demonstrable at least 6 hours after short acting B-2 agonist use or 12 hours
- •after long acting B-2 agonist use) at baseline.
- •- >1 documented severe asthma exacerbations despite daily high dose ICS
- •plus LABA (long acting inhaled ß2-agonist) within one year prior to screening
- •Note: 1). Patients who do not have documentation of reversibility and/or skin prick test in
- •previous one year, will have to undergo tests at screening. 2). The patients should meet all
- •of the above criteria to be included in the study.
- •3). Able to understand the study procedures, the risks involved, willing to provide written
- •Informed Consent, and able to adhere to study schedules and requirements.
- •4). Subjects must have the ability to understand and comply with instructions and be
- •able to complete study-related forms and questionnaires.
- •5). Men and women of childbearing potential must be using adequate birth control
- •measures, as discussed with the study doctor and should agree to continue such
- •precautions for 6 months after receiving the last injection of study medication
- •6). Menopausal females must have experienced their last period more than 12 months
- •prior to study entry to be classified as not of childbearing potential.
排除标准
- •1. Any Clinically significant abnormal laboratory investigations or physical
- •examination findings which may pose risk to the patients as assessed by
- •investigator at screening visit.
- •2. Prior Hospitalisation or an emergency visit for asthma within the 4 weeks before
- •the screening Visit.
- •3. Patient with history of near fatal or life-threatening (including intubation) asthma
- •within the past year prior to screening visit.
- •4. Patients with a history of allergic reactions attributed to compounds of similar
- •chemical or biologic composition to Omalizumab or its any excipients. History of
- •illicit drug use within one year prior to screening.
- •5. Prior use of Omalizumab (or any biological treatment of Allergic Asthma)
- •6. Known history of systemic (injectable or oral) corticosteroid medication use within
- •1 month of the Screening Visit.
- •7. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive
- •pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis etc.).
- •8. Subject has a smoking history equivalent to 10 pack years (i.e., at least 1 pack of
- •20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.).
- •9. Current smoker or smoking history within 12 months prior to the Screening Visit.
- •10. Current signs or symptoms of significant, progressive or uncontrolled renal,
- •hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic
- •or cerebral disease that renders the patient incapable of participating in the study.
- •11. Inability to comply with study and/or follow-up procedures.
- •12. Subjects with HIV, HBsAg, HCV test positive.
- •13. History or presence of any form of cancer within the 10 years prior to screening.
- •14. Participation in any clinical study of an investigational product within the previous
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