Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Formoterol 6mcg + Budesonide 200mcg
: 2 puffs BD through pMDI and Spacer
Control Intervention1: Formoterol 6mcg + Glycopyronium 12.5mcg: 2 puffs BD through pMDI and Spacer
Sponsors
Cipla Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age more than equal to 35 years 2 Gender Female and Male 3 Exposure to biomass fuel like wood Animal dung crop residues The Biomass Exposure Index BEI should be more than equal to 60 This index is calculated as the average hours spent on cooking per day multiplied by the number of years of cooking Accordingly patients can be recruited if they have a history of exposure such as 2 hours per day for 30 years 3 hours per day for 20 years or 4 hours per day for 15 years or any other exposure duration leading to a BEI of more than equal to 60 4 Symptoms Either one of the symptoms should be present Cough Shortness of breath Wheeze Chest tightness 5 Spirometry Post BD FEV1 by FVC more than 70 percentage and FEV1 percentage pred more than 80 percentage but less than 30 percentage. Spirometry will be conducted at screening for the naïve subjects and previously diagnosed cases of COPD Spirometry tests to be scheduled basis the time of the last inhaler taken in advance of the date of the test with appropriate instructions given to the patient for withholding the next dose and the time at which they need to report for the test
Exclusion criteria
Exclusion criteria: 1 Subjects unwilling to sign the informed consent 2 Subjects unwilling to come for the follow up visits 3 BEI of less than 60 4 Subjects with a current diagnosis of Asthma or Bronchiectasis 5 Any form of tobacco smoking that is Bidis cigarettes hookahs chillum etc 6 History of Pulmonary TB treated and cured in the past 7 Subjects on current oral corticosteroids 8 Hypersensitivity to glycopyrronium or formoterol or budesonide or levosalbutamol or any of its components 9 Subjects with any hospitalization required for severe exacerbation or any serious condition within past 12 weeks from screening 10 Subjects requiring oral/parenteral corticosteroids within past 4 weeks from screening 11 Subjects requiring oxygen therapy at least 12 hours daily in past 4 weeks from screening 12 Clinically significant ECG abnormality 13 Clinically significant neurologic cardiovascular hepatic renal endocrine pulmonary post tuberculosis fibrosis pulmonary fibrotic disease pulmonary arterial hypertension hematologic psychiatric or other medical illness that will interfere with participation in this study 14 History of asthma present or past rule out complete history and examination of asthma and/or post bronchodilator FEV1 values greater than 400ml of predicted normal values with persistent airflow limitation or history of atopy or any other chronic respiratory disease other than COPD 15 Life threatening unstable respiratory disease including lower respiratory tract infection, within past 4 weeks from screening 16 History of lung resection of more than one full lobe 17 Scheduled for in patient hospitalization including elective surgery during the trial 18 History of clinically significant bladder neck obstruction or urinary retention 19 History of glaucoma 20 History of uncontrolled diabetes mellitus 21 Participation in clinical trial in within past 4 weeks of screening. 22 Female who is pregnant or lactating or planning to be pregnant. 23 Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator 24 Subjects on triple therapy on all combinations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Mean change in trough FEV1 2 Mean change in trough FVC 3 Mean change in CAT scores 4 Proportion of subjects with a more than equal to 2 unit decrease in CAT 5 Proportion of subjects classified based on CAT severity as Low 0 to 10 medium 11 to 20 high 21 to 30 and very high 31 to 40 6 Mean change in R5 R5 minus R20 X5 Ax difference in X5 and Fres 7 Mean change in R5 R5 minus R20 and AX 8 Mean change in SGRQ C scores 9 Mean change in mMRC grades 10 Number of mild or moderate or severe exacerbations 11 Requirement of rescue medications and frequency 12 Adverse events treatment emergent adverse events and serious adverse events Timepoint: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline 4 From baseline to 24 weeks 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks 11 From Baseline V0 or Randomization V1 to V2 which is | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDeesha Deepak Ghorpade
Chest Research and Training (CREST)
Outcome results
None listed