CTRI/2023/08/056250尚未招募4 期
A prospective, single arm, multicentre, postmarketing,real world clinical study to assessthe efficacy and safety of Formoterol fumarateand Fluticasone propionate powder forinhalation (Formoflo 250) in the patients withAsthma - NI
upin Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Patients of either gender between 18-65 years of age (both inclusive)
- •2. Patients with mild to moderate asthma not receiving any regular
- •controller medication since last 12 weeks
- •3. Patients with bronchodilator reversibility i.e., increase in FEV1 of >= 12% and >= 200 ml after salbutamol inhalation at screening
- •4. Pre-bronchodilator FEV1 of 60% to 85% of the predicted normal value at screening
- •5. Patients with Asthma Control Test (ACT) score <= 15 at screening
- •6. Patients willing to provide written informed consent and comply with the
- •protocol requirements
排除标准
- •1. Known hypersensitivity to any β2-agonist, sympathomimetic drug, or any
- •inhaled, intranasal or systemic corticosteroid
- •2. History of life-threatening asthma within past 5 years prior to screening
- •3. Asthma exacerbation requiring systemic corticosteroids or that resulted in
- •hospitalization within 6 months prior to screening
- •4. Patients diagnosed with COVID-19 within 3 months prior to screening
- •5. Suspected or confirmed bacterial or viral infection of the upper or lower
- •respiratory tract, sinus or middle ear within 4 weeks prior to screening
- •6. Patients with concurrent respiratory disorder other than asthma such as but
- •not limited to pneumonia, pulmonary tuberculosis, chronic bronchitis, chronic
- •obstructive pulmonary disease, pneumothorax, atelectasis,
- •bronchopulmonary dysplasia, interstitial lung disease, cystic fibrosis
- •7. Clinical evidence of oropharyngeal candidiasis at screening
- •8. Patients with clinically significant uncontrolled systemic diseases such as
- •cardiovascular, renal, neurological, psychiatric, endocrine, immunological or
- •hematological disorders or malignancy
- •9. Patients with hepatic dysfunction (serum transaminases >= 3 x Upper Normal
- •Limit) or renal dysfunction (serum creatinine
- •10. >= 2.5 mg/dl) at screening
- •11. Patients who have used prohibited medications
- •12. Pregnant or Lactating females; or female patients of childbearing potential
- •unwilling to use effective contraception
- •13. Current smokers or ex-smokers who have stopped smoking within 6 months
- •prior to screening or have a smoking history of at least 10 pack-years
- •14. Patients with continuing history of alcohol and/or drug abuse
- •15. Participation in another clinical trial within 3 months prior to screening
- •16. Any other reason for which the investigator feels that the patient should not
- •participate
研究者
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