CTRI/2019/01/016974已完成4 期
An Open-Label, Non–Comparative Phase-IV Study to Evaluate the Efficacy, Safety and Tolerability ofTulobuterol Transdermal Patch –0.5/1/2 mg (Tuloplast™) in Patients with Asthma or COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
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
- •A. For Children < 6 years of age-
- •1. Children aged < 6 years or younger with a history of physician diagnosed asthma at the time of giving informed consent
- •2. Children experiencing more than one of the following symptoms: wheeze, cough, shortness of
- •breath, activity limitation and/or nocturnal awakening
- •3. Parents or guardians of the patients willing to give informed consent and willing to comply with the clinical study protocol
- •B. For Children > 6-11 years of age-
- •1. Children aged > 6 to 11 years with a history of physician diagnosed asthma at the time of giving informed consent
- •2. Children experiencing more than one of the following symptoms: wheeze, cough, shortness of
- •breath and/or nocturnal awakening
- •3. Children who meet one of the following criteria in terms of pulmonary function parameters:
- •i. The FEV1/FVC ratio less than 0.90
- •ii. Increase in FEV1 of > 12% predicted (post bronchodilator usage) from baseline, 10-15
- •minutes after 200-400 mcg salbutamol or equivalent as per GINA 2018
- •4. Parents or guardians of the patients willing to give written informed consent and willing to comply with the clinical study protocol
- •5. Children who give assent to participate in the study (Participants of appropriate intellectual maturity should personally sign and date a separately designed, written assent form. For other patients verbal assent is admissible)
- •C. Asthma (Adolescent and Adult Patients)-
- •1. Male or female patients aged = 12 years at the time of giving informed consent
- •2. Patients experiencing more than one of the following symptoms: wheeze, cough, chest tightness,shortness of breath and/or nocturnal awakening
- •3. Patients who meet one of the following criteria in terms of pulmonary function parameters:
- •i. FEV1/FVC: less than 0.75
- •ii. Bronchodilator reversibility: increase in FEV1 of >12% and >200mL from baseline, 10-15
- •minutes after 200-400 mcg salbutamol or equivalent
- •4. Patients whose asthma is not controlled by low dose Inhaled Corticosteroids (ICS) alone E.g. Budesonide (200-400 mcg)
- •5. Patients willing to give written informed consent (parents or guardians in case of adolescent patients; adolescent patients will have to sign an informed assent form) and willing to comply with the clinical study protocol
排除标准
- •A. For children aged 6 months to 11 years-
- •1. Patients with a known history of hypersensitivity to the study medication
- •2. Patients with dermatological diseases, including atopic dermatitis
- •3. Patients showing evidences of pulmonary infection
- •4. Major organ disorders like liver or kidney failure
- •5. Patients with history of poorly controlled associated diseases such as: heart disease, hypertension,thyroid disorders and diabetes
- •6. Patients who are otherwise judged to be inappropriate for inclusion in the study by the investigator (for whom treatment with ß2 agonists is considered inappropriate)
- •B. Asthma (Adolescent and Adult Patients)-
- •1. History of smoking during 6 months preceding enrollment
- •2. Acute exacerbation of asthma (Patients can be included after stabilization)
- •3. Patients with dermatological diseases, including atopic dermatitis
- •4. Patients with respiratory disease other than asthma (e.g., emphysema, bronchiectasis, pulmonary fibrosis, lung cancer, sarcoidosis)
- •5. Any existing pulmonary infection
- •6. Female patients who are pregnant or breastfeeding or are planning to get pregnant within 2 months after initiation of the study
- •7. Illness severe enough to require hospitalization
- •8. Patients with a known history of hypersensitivity to the study medication
- •9. Major organ disorders like liver or kidney failure
- •10. Patients with history of poorly controlled associated diseases such as: heart disease, hypertension,thyroid disorders and diabetes
- •11. Patients who are otherwise judged to be inappropriate for inclusion in the study by the investigator (for whom treatment with ß2 agonists is considered inappropriate)
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