CTRI/2021/11/037790已完成3 期
A prospective, randomized, double-blind, parallel, active-controlled, multicentre, phase III clinical trial to assess the efficacy and safety of Vilanterol and Fluticasone furoate metered dose inhalation as compared to Formoterol fumarate and Fluticasone propionate metered dose inhalation in the patients with persistent asthma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
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. Patients of either gender between 18-65 years of age (both inclusive)
- •2. Patients diagnosed with asthma for at least 6 months prior to screening
- •3. Patients receiving low to mid dose ICS-LABA with stable doses for ââ?°Â¥ 4 weeks prior to screening
- •4. Pre-bronchodilator FEV1 of 40% to 80% of the predicted normal value at screening
- •5. Patients with bronchodilator reversibility i.e., increase in FEV1 of ââ?°Â¥ 12% and ââ?°Â¥ 200 ml after salbutamol inhalation at screening
- •6. Patients with Asthma Control Test (ACT) score ââ?°Â¤ 15 at screening
- •7. Patients willing to provide written informed consent and comply with the protocol requirements
- •8. Patients literate enough to fill the diary card
排除标准
- •1. Known hypersensitivity to any Ã?²2-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 ââ?°Â¥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ââ?°Â¥ 2.5 mg/dl) at screening
- •10. Patients who have used prohibited medications
- •11. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- •12. 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
- •13. Patients with continuing history of alcohol and/or drug abuse
- •14. Participation in another clinical trial within 3 months prior to screening
- •15. Any other reason for which the investigator feels that the patient should not participate
研究者
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