CTRI/2014/01/004370尚未招募3 期
An Open-label, Prospective, Three Arm, Parallel Group, Randomized, Multicentric Phase-III Clinical Study to Evaluate the Efficacy and Safety between monotherapy of oral Roflumilast 0.5mg Tablet and combination therapy of Roflumilast 0.5 mg tablet plus Salmeterol 25mcg oral inhaler and combination therapy of Roflumilast 0.5 mg tablet plus Tiotropium 9mcg oral inhaler in adult patients with Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 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
- •1)Male or female patients aged 35-65 years.
- •2)Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits and compliance with protocol requirements as evidenced by providing written informed consent
- •3)COPD patients having at least one documented moderate or severe exacerbation within one year prior to baseline visit.
- •4)FEV1 <= 50% of predicted.
- •5)FEV1/FVC ratio <= 70%.
- •6)Patients already on therapy for COPD with beta2 adrenergic receptor agonists / muscarinic receptor antagonists / Xanthine class of drugs.
- •7)Presence of respiratory symptoms of COPD including dyspnea, cough and sputum production.
- •8)Current smokers or patients with a history of smoking.
- •9)For women of child-bearing potential: women is not pregnant (and has to undergo urine pregnancy test at the time of screening which must be negative) and not nursing, and is practicing an acceptable method of birth control.
排除标准
- •1)Inability to adequately perform spirometry.
- •2)COPD exacerbation indicated by a treatment with systemic corticosteroids and/or antibiotics not stopped within 4 weeks prior to screening visit and remains uncontrolled in between the treatment periods.
- •3)Diagnosis of asthma and/or other relevant lung disease.
- •4)Suffering from any concomitant disease that might interfere with study procedures or evaluation.
- •5)Lower respiratory tract infection not resolved 4 weeks prior to the screening visit.
- •6)Known clinically significant cardiopulmonary abnormalities (diagnosed clinically or documented by X-ray or ECG) and are not related to COPD and that require further evaluation.
- •7)Known case of HIV and/or patient currently on cytotoxic drugs.
- •8)Hepatitis and/or liver insufficiency (SGOT and/or SGPT >= 5 times the upper limit of the normal reference range)
- •9)Renal insufficiency (S. Creatinine >= 5 times the upper limit of the normal reference range)
- •10)Known or suspected hypersensitivity to the study drug or its components.
- •11)Known or suspected hypersensitivity to milk-proteins.
- •12)Participation in another clinical trial within the last 30 days, simultaneous participation in
- •another clinical trial, or previous participation in this trial.
- •13)History of, or known current problem with, substance abuse, or any medical, psychological, and/or social condition that may interfere with the patients participation in the study, or with evaluation of the study results.
- •14)Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures.
- •15)Have any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety of the study drug according to the study protocol (e.g., poorly compliant subject).
研究者
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