Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
Conditions
Interventions
Intervention1:
Neb GFB
: Nebulized fixed-dose Glycopyrronium 25 microgram plus Formoterol 20 microgram plus Budesonide 500 microgram administered via jet nebulizer BID in ER or ICU and during ward s
Sponsors
Dr Bharat Mehrotra
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 40 years, either gender 2. Currently, ICU/ER hospitalisation for AECOPD as primary diagnosis (per GOLD criteria: acute worsening of respiratory symptoms requiring additional therapy) 3. Either patient or LAR is willing to provide informed consent and comply with study procedures 4. Willingness to attend follow-up assessments.
Exclusion criteria
Exclusion criteria: 1. History of current hospitalization with life threatening condition other than COPD or patients with acute exacerbation of asthma (acute condition). 2. Primary diagnosis of asthma, interstitial lung disease, pulmonary fibrosis, or bronchiectasis 3. Pregnant or nursing women. 4. Women of childbearing potential are not restricted in this study, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment. 5. Subjects with history of hypersensitivity to the active substance or to any of its excipients of study drug. 6. Subjects with history of pneumonia in last 3 months 7. Any condition that, in investigator judgment, precludes safe participation or reliable data capture (e.g., inability to collect baseline biomarkers within window).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare time to clinical recovery in hours in acute exacerbation of COPD between patients receiving Neb GFB versus those receiving SABA SAMA plus Budesonide. Timepoint: Time to clinical recovery equal to number of hours or days from the first dose of study treatment Time to the first observation point at which all improvement criteria are met and remain stable for Greater than equal to 12 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| In-hospital phase 1.To compare mean change in PEFR after initial BD administration. 2.To compare proportion of patients achieving clinical recovery of exacerbation. 3.Comparison of use of rescue medications doses. 4.To compare number of patients requiring FiO2 or ventilation support 5.To compare total number of additional systemic steroid doses administered in individual groups 6.Change in CRP, PCT, and eosinophil counts 7.Proportion of patients with change in ECG parameters in ICU or ER 8.To compare average length of ICU stay, ward stay and total hospital stay. Timepoint: 1.PEFR will be measured at baseline pre-dose, 15 min, 30 min, 1 hr., 3 hr., 6 hr. and 12 hr after the first nebulization on Day 1 then on Day 3, 5, and 7. 2.Patients achieving clinical recovery of exacerbation on day 1, 3, 5 3.Patients requiring FiO2 or ventilation support on day 1, 3, 5, 7 4.Change in CRP, PCT, and eosinophil counts from baseline, on day 1, 3, 5, 7 ;Post-discharge 1.To compare time to first exacerbation 2.Proportions of re-admissions. 3.To compare trough FEV1 between group. 4.To compare symptom control and QoL. 5.To assess use of rescue medication. 6.Evaluate all-cause mortality. Safety 7.No. of patients with drug related TEAEs, other TEAE & STEAEs. Timepoint: 1.Proportions of re-admissions between groups upto Day 30, 60 and 90. 2.Compare trough FEV1 between group on day 15, 30, 60, 90 3.mMRC dyspnea score on day 15, 30, 60, 90 4.Evaluate all-cause mortality through Day 90 | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
New Leelamani Hospital
Outcome results
None listed