A randomized, double blind, prospective, single dose, placebo-controlled, cross over study to evaluate efficacy and safety of arformoterol inhalation solution (R,R-Formoterol) delivered by a nebulizer in subjects with chronic obstructive pulmonary disease (COPD)

Cipla Ltd0 个研究点目标入组 211 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Subjects willing to give a written informed consent.
•2. Subjects aged 35 years and above.
•3. Subjects diagnosed with COPD as per GOLD guidelines (FEV1/FVC < 70% and FEV1 < 80% predicted) with FEV1 <65% of predicted normal value and >0.70 L at screening visit.
•4. Smoking history of at least 10 pack-years.

•1. Subjects requiring continuous supplemental oxygen therapy. The use of supplemental oxygen, not exceeding 2 L/minute, at night time only and/or only during exercise is allowed.
•2. Change in dose or type of any medications for COPD within 14 days prior to the screening visit.
•3. History of asthma or any chronic respiratory disease other than COPD.
•4. Hospitalization for pulmonary exacerbation within the past 2 months.
•5. Life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days.
•6. History of lung resection of more than one full lobe.
•7. Using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers).
•8. Absolute Blood eosinophil count >600 cells/c mm of blood.
•9. Have a known sensitivity to formoterol, ipratropium, salbutamol, levosalbutamol or any of the excipients contained in any of these formulations.
•10. Treatment with any other investigational drug in last 30 days prior to screening

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