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Comparison of N-acetylcysteine and ambroxol for symptom improvement in patients with COPD after acute exacerbation

Comparative Effectiveness of N-Acetylcysteine and Ambroxol in Reducing Cough Symptom Scores and COPD Assessment Test Scores Among Patients with COPD Following Acute Exacerbation: A Prospective Randomized Open Blinded Endpoint Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260523016
Enrollment
50
Registered
2026-05-23
Start date
2025-10-07
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD) following acute exacerbation Chronic Obstructive Pulmonary Disease, N-acetylcysteine, Ambroxol, Mucolytic Agents, Cough, COPD Assessment Test

Interventions

N-acetylcysteine 200 mg was administered orally three times daily for 14 days in addition to standard COPD therapy following hospitalization for an acute exacerbation.,Ambroxol 30 mg was administered
Active Comparator Drug,Active Comparator Drug
N-Acetylcysteine,Ambroxol

Sponsors

Universitas Gadjah Mada
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 40 years and older with a diagnosis of acute exacerbation of chronic obstructive pulmonary disease who had been hospitalized and continued outpatient treatment 2. Patients who received either N-acetylcysteine or ambroxol as additional therapy after hospitalization 3. Patients who were able to communicate and complete study questionnaires 4. Patients who agreed to participate and provided written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with clinical diagnoses of lung cancer, bronchiectasis, tuberculosis, or interstitial lung disease 2. Patients with severe hepatic disorders, renal disorders, psychiatric disorders, hematologic disorders, or malignancy that could interfere with study participation based on medical record evaluation 3. Patients receiving other cough medications outside the assigned intervention during the study period

Design outcomes

Primary

MeasureTime frame
Cough symptom severity At baseline and 14 days after intervention Cough Symptom Score questionnaire assessing daytime and nighttime cough symptoms

Secondary

MeasureTime frame
Health status in patients with chronic obstructive pulmonary disease At baseline and 30 days after intervention COPD Assessment Test questionnaire

Countries

Indonesia

Contacts

Public ContactLuthfiah Pertiwi

Universitas Gadjah Mada

luthfiahpertiwi@mail.ugm.ac.id6282279809596

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026