CTRI/2024/07/071268尚未招募3 期
A Prospective, Randomized, Open-label, Parallel-group, Multi center, Active-controlled, Phase 3 Clinical Trial to Compare the Efficacy and Safety of FDC Erdosteine 300 mg and Acebrophylline 100 mg Tablet (of Macleods Pharmaceuticals Ltd.) versus FDC Acebrophylline 100 mg and Acetylcysteine 600 mg Tablet in Treatment of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease - NI
Ms Macleods Pharmaceuticals Ltd0 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
- 尚未招募
- 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.)Adult more than or equal to 40 years and less than or equal to 65 years of age (both ages inclusive). (2.)Post-bronchodilator FEV1 less than or equal to 80% but more than 50% of predicted normal. (3.)Post-bronchodilator FEV1/FVC ratio less than or equal to 0.70. (4.) Stable mild or moderate severity of COPD, based on COPD guidelines, GOLD 2023 and Guidelines for diagnosis and management of COPD: joint recommendations of Indian Chest Society and National College of Chest Physicians (India). (5.)Currently on maintenance therapy for stable COPD (tiotropium bromide rotacaps, each cap contains tiotropium bromide 18 mcg; administered as two inhalations of the powder contents of a single capsule [18 mcg] once daily; stable dose since at least 4 weeks prior to screening visit) and ability to continue to the same throughout the study period in the opinion of the investigator. (6.)Currently having symptom(s) of chronic bronchitis symptoms beyond normal day to day variation which require treatment at screening and randomization visit defined by Total cough symptom score of More than or equal to 4 and less than or equal to 12 and Total sputum symptom score Of More than or equal to 3 and less than equal to 9. (7.)Ability to discontinue expectorants, mucolytic or mucoregulatory agents, antitussives, long acting beta2 agonist, methylxanthines, short-acting muscarinic receptor antagonists, long-acting muscarinic receptor antagonists (except tiotropium bromide), systemic antibiotics, inhaled corticosteroids, antidepressants, neuroleptics during the wash-out period and for remainder of the study in the opinion of the investigator. (8.)Have not used oral or systemic corticosteroids within last 6 months prior to screening visit. (9.)Ability to use short-acting Beta2 agonists (SABAs) as needed for the duration of the study; subjects should be able to withhold all SABAs for at least 6 hours prior to lung function assessments on study visits. (10.)Women of child-bearing potential or women who are postmenopausal less than or equal to 12 months prior to screening visit must have negative urine pregnancy test prior to randomization visit. (11.)Willingness to comply with all aspects of the study protocol. (12.)Willingness to give their informed consent to participate in the study.
排除标准
- •1.Post-bronchodilator FEV1 less than 50 % of predicted normal during screening visit.
- •2.Known respiratory disorders other than COPD including, but not limited to the following alpha-1 antitrypsin deficiency, cystic fibrosis, bronchial asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, interstitial lung disease, lung malignancy.
- •3.History of other clinically significant disease or abnormality (such as congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, stroke, glaucoma, or cardiac dysrhythmia, hypotension, arrhythmias, atopy, allergy, renal disease, uncontrolled diabetes liver disease, convulsive disorders, ulcer).
- •4.Known active tuberculosis.
- •5.History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, urinary obstruction or any other condition which, would contraindicate the use of an anticholinergic agent.
- •6.History of allergy or hypersensitivity to erdosteine, acebrophylline, or any other xanthine derivative, or short acting beta2 agonist, and/or acetylcysteine.
- •7.Hospitalization for COPD or pneumonia or chronic bronchitis symptoms within 12 weeks prior to the initiation of the study.
- •8.Treatment for COPD exacerbation within 12 weeks prior to study.
- •9.Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 6 weeks prior to screening visit.
- •10.Abnormal and significant ECG finding prior to the screening visit.
- •11.Lung volume reduction surgery within 12 months prior to the initiation of the study.
- •12.Chronic oxygen use for more than 12 hours per day.
- •13.Severe COPD or symptoms of chronic bronchitis requiring systemic corticosteroids.
- •14.Presence of complications indicating respiratory failure.
- •15.Women who are pregnant or lactating or planning pregnancy during the study.
- •16.Known history of alcohol or drug/substance abuse.
- •17.Have participated in any other clinical trial within 1 month prior to screening visit.
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