Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
Conditions
Interventions
Intervention1: Glycopyrrolate/Formoterol: Administered as dry powder inhaler (25 µg/6 µg)twice daily for 6 months
Control Intervention1: Tiotropium/Formoterol: Administered as dry powder inhaler (18
Sponsors
SRM COLLEGE OF PHARMACY SRMIST
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ex-smokers 2.Clinical history of moderate to severe COPD, (Global Initiative for Chronic Obstructive Lung Disease [GOLD] Stage II or III according to 2019 GOLD guidelines) 3.Post bronchodilator forced expiratory volume in 1 second (FEV1 ) >= 30% and 4.Post bronchodilator FEV1/forced vital capacity (FVC)
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women 2.Known history of psychiatric illness 3.Moderate or severe renal impairment 4.Patients with urinary retention 5.Narrow-angle glaucoma 6.Known history of alpha-1 antitrypsin deficiency 7.Other underlying respiratory diseases other than COPD 8.Surgeries including lobectomy or bronchoscopic lung volume reduction 9.Inability to produce acceptable/reproducible spirometry results 10.Contraindications to Glycopyrrolate, Formoterol or Tiotropium 11.History of adverse reactions to inhaled anticholinergics 12.Patients with known malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in FEV1/FVC ratio at the end of 12th weekTimepoint: 4th, 8th and 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in FEV1, health status using St.Georges Respiratory Questionnaire (SGRQ), number of COPD exacerbationsTimepoint: 4th, 8th and 12th week | — |
Countries
India
Contacts
Public ContactManali Sudhir Dhage
SRM College of Pharmacy,SRMIST
Outcome results
None listed