CTRI/2018/09/015862暂停未知
An open-label, multicenter, randomized, comparative study to evaluate efficacy and safety of Respiforb® inhalation powder, pre-dispensed 320+9 μg/dose (Sava Healthcare Limited, India) and Symbicort® Turbuhaler®, inhalation powder, pre-dispensed 320+9 μg/dose (AstraZeneca AB, Sweden) in patients with partly controlled asthmaâ??
PSK Pharma LLC0 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
- 未知
- 状态
- 暂停
- 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. Availability of a signed copy of the Informed Consent Form of the Patient Information Leaflet.
- •2. Male and female patients 18 to 70 years of age (inclusive) at the moment of signing the Informed Consent Forms (ICF).
- •3. Diagnosis of persistent asthma established according to the GINA guidelines (2017) not less than 6 months prior to the screening visit.
- •4. Asthma that is inadequately controlled by inhaled corticosteroids (ICS) inhaled corticosteroids and short-acting beta-agonists (SABA) as on-demand therapy.
- •5. Need to use bronchodilatory therapy with a combination of ICS and long-acting beta agonists (LABA).
- •6. ACQ-5 score >=0.75 and <1.5
排除标准
- •1. Patients who need the selection of initial maintenance therapy for asthma.
- •2. Contraindications for use of ICS, hypersensitivity to budesonide, formoterol, salbutamol, inhaled lactose or to any other component of the study drugs.
- •3. Lactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
- •4. A diagnosis of chronic obstructive pulmonary disease (COPD) established according to the 2017 version of the GOLD guidelines.
- •5. Excessive requirement of SABA
- •6. Use of oral or parenteral corticosteroids within 2 months prior to the screening visit (3 months for extended-release parenteral ICS).
- •7. The use of immunosuppressive agents (e.g., cyclosporine, methotrexate, tumor necrosis factor (TNF) inhibitors or anti-TNF-antibodies, gold salts, azathioprine) within 4 weeks prior to the screening visit.
- •8. Conditions that require the use of systemic therapy with corticosteroids at the time of the screening visit.
- •9. Unexpected progressive deterioration of asthma symptom control.
- •10. A history of a nearly fatal asthma attack (e.g., unstable asthma, hospitalization due to asthma exacerbation to ICU with the use of intubation).
- •11. Pulmonary tuberculosis (active or inactive form).
- •12. Fungal, viral, or bacterial respiratory tract infections, or systemic viral infection, Herpes simplex-related eye disease at the moment of the screening visit.
- •13. Lower respiratory tract infection within 1 month prior to the screening visit.
- •14. Cystic fibrosis, bronchiectasis, pneumoconiosis.
- •15. Restrictive ventilatory defects.
- •16. Uncontrolled hypokalemia, hypocalcaemia.
- •17. Thyrotoxicosis.
- •18. Osteoporosis.
- •19. Glaucoma, cataract.
研究者
相似试验
尚未招募
不适用
Study of the efficacy and safety of Tiotropium bromide,in patients with COPD.CTRI/2017/10/010024Rus Biopharm LLC
进行中（未招募）
1 期
A clinical trial to assess the efficacy and safety of pritelivir for the treatment of Herpes Simplex Virus infections on the skin and mucous membranes which is resistant to acyclovir in subjects with weakened immune system.Acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjectsEUCTR2020-004940-27-DEAiCuris Anti-infective Cures AG153
进行中（未招募）
1 期
A clinical trial to assess the efficacy and safety of pritelivir for the treatment of Herpes Simplex Virus infections on the skin and mucous membranes which is resistant to acyclovir in subjects with weakened immune system.Acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjectsEUCTR2020-004940-27-BEAiCuris Anti-infective Cures AG153
进行中（未招募）
1 期
A clinical trial to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of Herpes Simplex Virus infections on the skin and mucous membranes which is resistant to acyclovir in subjects with weakened immune system.Acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjectsMedDRA version: 20.0Level: HLTClassification code 10019972Term: Herpes viral infectionsSystem Organ Class: 100000004862EUCTR2020-004940-27-ITAiCuris Anti-infective Cures GmbH128
招募中
3 期
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects2023-510088-37-00AiCuris Anti-infective Cures AG54