A randomized, open label, active-controlled, parallel group, multicenter 6weeks study to determine safety, tolerability and efficacy of nebulisedformulation of Formoterol Budesonide combination in comparison withpressurized meter dose formulation of Formoterol Budesonide combinationin Chronic Obstructive Pulmonary Disease (COPD) patients

Cipla Ltd0 个研究点目标入组 112 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Patient and/or LAR willing to give a written informed consent.
•2. Patient of either sex aged above 40 years.
•3. Patient diagnosed with COPD as per GOLD guidelines (post
•bronchodilator FEV1/FVC ratio < 0.70)
•4. Patient with documented history of COPD for at least the past 6 months and who are on stable dose of COPD medication (monotherapy or combination) for at least 4 weeks prior to screening visit 1.
•5. Post-bronchodilator FEV1 Ã¢â?°Â¤50% of the predicted normal value (as per the European Community for Coal and Steel formula and applying the correction factor of 0.9) when not taking short-acting bronchodilator medication for the previous 6 hours, ICS+LABA atleast 24 hours, LABA+LAMA atleast 48 hours, LAMA atleast 48 hours prior to visit.
•6. Current and ex-smoker with a smoking history of at least 10 pack-years for cigarette and equivalent for bidi smoking.
•7. Patient able to use inhaler + Zerostat VT spacer and nebulizer in their respective groups

•1. History of asthma or any chronic respiratory disease other than COPD.
•2. Long term administration of supplemental oxygen (15 hours/day)
•3. Hospitalization for pulmonary exacerbation within the past one month or as per InvestigatorÃ¢â?¬•s discretion.
•4. Life-threatening/unstable respiratory status, including upper respiratory tract infection, within the previous 4 weeks or lower respiratory tract infection, within the previous 12 weeks.
•5. History of lung resection of more than one full lobe.
•6. Severe unstable or uncontrolled cardiovascular disorder, other pulmonary
•disease, clinically significant hematological, endocrine, electrolyte, renal or hepatic abnormality
•7. Any clinically significant lab values as per investigators discretion.
•8. Pregnant or lactating or planning to become pregnant
•9. Have a known hypersensitivity to Investigational product or any of the excipients contained in study medicines.
•10.Treatment with any investigational drug in last 30 days prior to screening visit 1.

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