To assess safety, efficacy and tolerability of Formoterol Budesonide nebulised formulationin comparison with Formoterol Budesonide pressurized meter dose formulation inCOPD patients

Phase 4

Completed

• Conditions: Health Condition 1: null- Patient diagnosed with COPD

• Registration Number: CTRI/2012/11/003087
• Lead Sponsor: Cipla Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-11-28
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

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 �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

Exclusion Criteria

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 Investigatorââ?¬•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in pre-bronchodilator FEV1 & FVC between both the groupsTimepoint: Mean change in pre-bronchodilator FEV1 & FVC between both the groups

Secondary Outcome Measures

Name	Time	Method
Change in COPD questionnaire at week 6 from baselineTimepoint: During study period;Change in post-bronchodilator FEV1Timepoint: 2 and 4 weeks;Change in post-bronchodilator FVCTimepoint: 2 and 4 weeks;Change in pre and post bronchodilator FEF25-75 between both the groupsTimepoint: baseline to end of 6 weeks;Difference in use of number of puffs of rescue medicationTimepoint: During study period;Incidence of adverse eventsTimepoint: During study duration;Incidence of COPD requiring emergency attendance, treatment with oral steroid and hospitalizationTimepoint: During study duration;Incidence of drug related adverse eventsTimepoint: During study duration;Mean change in post-bronchodilator FEV1 between both the groupsTimepoint: baseline to end of 6 weeks