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Study on utilization of glycopyrronium and arformoterol inhalation as a treatment for COPD.

Clinical assessment of glycopyrronium and arformoterol home nebulization in high-risk, symptomatic COPD: SYMPTOM study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/07/020144
Enrollment
40
Registered
2019-07-10
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

Interventions

Intervention1: NIL: NIL

Sponsors

Glenmark Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Hospitalized or Post-discharge cases of COPD 2. COPD cases with history of >=1 exacerbation in last year 3. Patients willing for follow-up visit.

Exclusion criteria

Exclusion criteria: 1. Patients with 2. Personal history of Bronchial asthma 3. Patients with history on use of oxygen therapy >12 hours/day 4. Patients with any history of unstable disease and/or recent hospitalization due to COPD prior to six weeks of study observation

Design outcomes

Primary

MeasureTime frame
Assessment of 1. Intergroup differences for percentage patients requiring Anticholinergics in Hospitalized or out-patient cases. 2. Pre-bronchodilator PEFR or FEV1 improvement at 4 weeks. 3. Change in CAT score at 4 weeks.Timepoint: 4 weeks

Secondary

MeasureTime frame
Assessment of common adverse events (1%)Timepoint: 4 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