CTRI/2017/07/009000进行中（未招募）3 期
A multi-center, randomized, 12-week treatment, doubleblindstudy to assess the efficacy and safety of QMF149(150/80 microgram) compared with MF Twisthaler® (200microgram) in adult and adolescent patients with asthma. - NA
ovartis Healthcare Private 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
- 3 期
- 状态
- 进行中（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
- Interventional
入排标准
入选标准
- •1. Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit.
- •2. Patients who have used low dose ICS , with or without controller (i.e. LABA, Leukotriene Receptor Antagonist) at stable dose for at least 1 month prior to Screening Visit.
- •3. Adult patients who are symptomatic at screening despite treatment with existing therapy.
- •Patients with ACQ-7 score greater than equal to 1.5 at Visit 101 and at Visit 102 (inadequately controlled).
- •4. Pre-bronchodilator FEV1 greater than or equal to 60 percent and less than 90 percent of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102.
- •5. Patients who demonstrate an increase in FEV1 of 12 percent and greater than or equal to 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.
- •For Adolescent patients :
- •6. If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score greater than equal to 1.5 at Visit 101 and at Visit 102 .
- •If taking ICS (low dose)/ LABA, and have ACQ-7 score greater than or equal to 1 and less than 1.5 at Visit 101: they must have ACQ-7 score greater than or equal to 1.5 at Visit 102 (prior to randomization).
排除标准
- •1. Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year.
- •2. Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (greater than 24 hours) or emergency room visit (less than or equal to 24 hours) as follows:
- •2.a. For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation.
- •2.b. For adolescents: Exacerbation requiring systemic steroids, hospitalization (greater than 24 hours) or emergency room visit (less than or equal to 24 hours) within 6 months, prior to visit 1.
- •3. Patients who ever required intubation for a severe asthma attack/exacerbation.
- •4. Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
- •5. Patients with any chronic conditions affecting the upper respiratory tract, example chronic sinusitis, which in the opinion of the investigator may interfere with the study.
- •6. Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
- •7. Patients with Type I diabetes or uncontrolled Type II diabetes.
- •8. Patients with narcolepsy and/or insomnia.
- •9. Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
- •10. Patients with a clinical condition (example glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigators medical judgment )
- •11. Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.
研究者
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