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: Patient diagnosed with COPD

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

Brief Summary

This is a 6 weeks phase IV multicenter study to determine safety, tolerability and efficacy of nebulised formulation of Formoterol Budesonide combination in comparison with pressurized meter dose formulation of Formoterol Budesonide combination in Chronic Obstructive Pulmonary Disease (COPD) patients.  120 Patients will be enrolled into the study from at least 10 participating centers in Ixml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /ndia.  From these 120 patients, 80 patients will be given Formoterol Budesonide nebulization therapy and 40 patients will be given Formoterol Budesonide pMDI for the duration of 6 weeks.The primary end point of the study is to determine mean change in pre-bronchodilator FEV1 & FVC between both the groupsxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

from baseline to end of 6 weeks. Incidence of adverse events will be determined as safety endpoints. Incidence of COPD exacerbation requiring emergency attendance, treatment with oral steroid and hospitalization will also be observed.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-11
• Study Completion: 2013-11-28
• Last Update Posted: 2022-05-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patient and/or LAR willing to give a written informed consent.
• Patient of either sex aged above 40 years.
• 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.
• 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.
• Current and ex-smoker with a smoking history of at least 10 pack-years for cigarette and equivalent for bidi smoking.
• Patient able to use inhaler + Zerostat VT spacer and nebulizer in their respective groups.

Exclusion Criteria

• History of asthma or any chronic respiratory disease other than COPD.
• Long term administration of supplemental oxygen (15 hours/day) 3.
• Hospitalization for pulmonary exacerbation within the past one month or as per Investigator’s discretion.
• 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.
• History of lung resection of more than one full lobe.
• 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.
• 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 groups	Mean change in pre-bronchodilator FEV1 & FVC between both the groups

Secondary Outcome Measures

Name	Time	Method
Mean change in post-bronchodilator FEV1 between both the groups	baseline to end of 6 weeks
Change in post-bronchodilator FEV1	2 and 4 weeks
Change in post-bronchodilator FVC	2 and 4 weeks
Incidence of drug related adverse events	During study duration
Change in pre and post bronchodilator FEF25-75 between both the groups	baseline to end of 6 weeks
Difference in use of number of puffs of rescue medication	During study period
Incidence of adverse events	During study duration
Incidence of COPD requiring emergency attendance, treatment with oral steroid and hospitalization	During study duration
Change in COPD questionnaire at week 6 from baseline	During study period

Trial Locations

Locations (11)

AMC MET Medical College and L.G. Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Axon Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Chest Research Foundation; 🇮🇳 Pune, MAHARASHTRA, India

Ethika Clinical Research Centre; 🇮🇳 Thane, MAHARASHTRA, India

Fortis Flt Lt. Rajan Dhall Hospital; 🇮🇳 Delhi, DELHI, India

Fortis Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

M S Ramaiah Memorial Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Max Super Speciality Hospital; 🇮🇳 East, DELHI, India

Nagpur Chest Center; 🇮🇳 Nagpur, MAHARASHTRA, India

National Allergy Asthma Bronchitis Institute; 🇮🇳 Kolkata, WEST BENGAL, India

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AMC MET Medical College and L.G. Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Hiren Pandya

Principal investigator

09824030986

drhirenpandya@yahoo.com