A study to compare the effects of two different drug combinations namely Glycopyrrolate/Formoterol versus Tiotropium/Formoterol in patients with Chronic Obstructive Pulmonary Disease
- Conditions
- Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
- Registration Number
- CTRI/2020/01/022780
- Lead Sponsor
- SRM COLLEGE OF PHARMACY SRMIST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 <80% of predicted
4.Post bronchodilator FEV1/forced vital capacity (FVC) <0.70 at screening
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in FEV1/FVC ratio at the end of 12th weekTimepoint: 4th, 8th and 12th week
- Secondary Outcome Measures
Name Time Method Improvement in FEV1, health status using St.Georges Respiratory Questionnaire (SGRQ), number of COPD exacerbationsTimepoint: 4th, 8th and 12th week