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To determine efficacy of oral N-Acetyl Cysteine in patients with Chronic Obstructive Pulmonary Disease (COPD)

Comparative efficacy of oral N-Acetyl Cysteine Versus inhaled Fluticasone in Chronic Obstructive Pulmonary Disease Patients (COPD) - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/09/001988
Enrollment
40
Registered
2011-09-07
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: null- Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Intervention1: N-Acetyl Cysteine: N-Acetyl Cysteine 600 mg BD and placebo inhaler BD for 4 weeks in the morning between 8-10.a.m. and evening between 8-10 pm. Control Intervention1: Inhaled Fluticason

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and female patients between the ages of 40-75 years. 2.Patients diagnosed as COPD as per GOLD guidelines of all severities. 3.Informed written consent taken before start of the study.

Exclusion criteria

Exclusion criteria: 1.History of drugs such as ACE inhibitors, immunosuppressive medications. 2.History of drugs such as methysergide/ amiodarone. 3.Pregnant & lactating woman. 4.Patients suffering from active tuberculosis. 5.Significant cardiovascular, hepatic or renal impairment. 6.Participation in any clinical trial in past six months.

Design outcomes

Primary

MeasureTime frame
Change in FEV1 and FVCTimepoint: 4 weeks

Secondary

MeasureTime frame
Change in eCO levelsTimepoint: 4 weeks

Countries

India

Contacts

Public ContactDr Bill Brashier
bbrashier@crfindia.com09823834593

Outcome results

None listed

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