CTRI/2024/02/063046进行中（未招募）3 期
A prospective, randomized, parallel, activecontrolled,multicentre, phase III clinical trial toassess the efficacy and safety of Vilanterol,Glycopyrronium and Fluticasone furoatepowder for inhalation as compared toIndacaterol, Glycopyrronium and Mometasonefuroate powder for inhalation in patients withpersistent asthma - Nil
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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 12 months prior to screening
- •3. Pre-bronchodilator FEV1 of 40% to 80% of the predicted normal value at
- •4. Patients with bronchodilator reversibility i.e., increase in FEV1 of = 12% and =
- •200 ml after salbutamol inhalation at screening
- •5. Patients receiving ICS/LABA combination for asthma for at least 3 months
- •with stable dose of medium or high dose of ICS/LABA combination for = 4
- •weeks prior to screening
- •6. Patients who are symptomatic at screening defined as Asthma Control Test
- •(ACT) score = 15
- •7. Patients with a history of at least one severe asthma exacerbation within
- •past 12 months prior to screening
- •8. Patients willing to provide written informed consent and comply with the
- •protocol requirements
- •9. Patients literate enough to fill the diary card
排除标准
- •1. Known hypersensitivity to any ß2-agonist, sympathomimetic drug, antimuscarinic
- •agent 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 or emergency room visit within 6 weeks prior to screening
- •4. Patients treated with a long-acting muscarinic antagonist within 3 months
- •prior to screening
- •5. Patients with known diagnosis of narrow angle glaucoma, prostatic
- •hyperplasia, bladder-neck obstruction or urinary retention
- •6. Patients diagnosed with COVID-19 within 3 months prior to screening
- •7. Suspected or confirmed bacterial or viral infection of the upper or lower
- •respiratory tract, sinus or middle ear within 4 weeks prior to screening
- •8. 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
- •9. Clinical evidence of oropharyngeal candidiasis at screening
- •10. Patients with clinically significant uncontrolled systemic diseases such as
- •cardiovascular, renal, neurological, psychiatric, endocrine, immunological or
- •hematological disorders or malignancy
- •11. Patients with hepatic dysfunction (serum transaminases = 3 x Upper Normal
- •Limit) or renal dysfunction (serum creatinine = 2.5 mg/dl) at screening
- •12. Patients who have used prohibited medications
- •13. Pregnant or Lactating females; or female patients of childbearing potential
- •unwilling to use effective contraception
- •14. 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
- •15. Patients with continuing history of alcohol and/or drug abuse
- •16. Participation in another clinical trial within 3 months prior to screening
- •17. Any other reason for which the investigator feels that the patient should not
- •participate
研究者
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