Assessment of Glycopyrrolate in patients with breathing problems.

Clinical assessment of Glycopyrrolate in cOpd phenotypes, A drug utilizAtion surveilLance (GOAAL) study in outpatient settings of India - GOAAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/04/012944

Enrollment

1280

Registered

2018-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: null- COPD

Interventions

Intervention1: Glycopyrrolate 50 mcg DPI capsule: Glycopyrrolate 50 mcg, single dose (Morning) as add on to ICS/LABA (given Morning &/or Evening) for 12 weeks Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. COPD patients with GOLD B/C status who were symptomatic with more than or equal to 1 moderate to severe exacerbation in last six months that required antibiotics or short course oral corticosteroids 2. FEV1/FVC less than 0.7 with FVC less than 80%

Exclusion criteria

Exclusion criteria: Patients with less than 1 follow up visit to be excluded

Design outcomes

Primary

Measure	Time frame
Trough FEV1 improvementTimepoint: 4 weeks and 12 weeks	—

Secondary

Measure	Time frame
Change in CAT scoreTimepoint: 12 weeks;Treatment Emergent Adverse EventsTimepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr K Krishnaprasad

Glenmark Pharmaceuticals Ltd.

K.Krishna.Prasad@glenmarkpharma.com9820806811

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026