Using N-acetylcysteine to treat acute COPD flare-ups

A Double-Blind Randomized Controlled Trial of N-acetylcysteine (NAC) for the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

This study is testing if a medication called N-acetylcysteine can help people with COPD feel better during flare-ups by comparing it to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Queen Mary Hospital, Hong Kong (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT05706402 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of N-acetylcysteine (NAC) in treating acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). It focuses on assessing various clinical, physiological, and laboratory parameters, including oxygen levels and lung function, in patients experiencing acute COPD exacerbations. Participants will receive either high-dose NAC or a placebo to determine the impact on their symptoms and overall health outcomes. The study aims to provide insights into the potential benefits of NAC beyond its mucolytic properties.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and above with a diagnosis of COPD who are currently experiencing an acute exacerbation.

Not a fit: Patients who are on long-term NAC treatment or have contraindications to NAC will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of acute COPD exacerbations and enhance patients' quality of life.

How similar studies have performed: Previous studies have shown promising results with high-dose NAC in stable COPD patients, suggesting potential for success in this acute setting.

Eligibility criteria

Inclusion Criteria:

1. Aged 40 years or above, either male or female.
2. Patients who are current or ex-smokers

   * Ever-smoker is defined as having smoked at least one cigarette, pipe, water pipe, cigars, or hand rolled cigarettes a day for 1 or more years.
3. Patients with a pre-existing diagnosis of COPD admitted to the general medical and respiratory subspecialty wards for acute COPD exacerbation

   * COPD is defined as dyspnoea and/or chronic productive cough with spirometry confirmation of persistent airflow limitation at FEV1/FVC less than 70%.
   * COPD acute exacerbation is defined as an acute increase in symptoms (one or more of the following: cough frequency and severity, sputum production, dyspnoea) beyond normal day-to-day variations leading to a change in medication.
4. Patients who consent to join this clinical trial

Exclusion Criteria:

1. Patients who are on long-term NAC treatment
2. Patients who are not able to take NAC including drug allergy
3. Patients with other co-existing respiratory diseases including but not limited to asthma, interstitial lung diseases, and bronchiectasis
4. Patients on non-invasive or invasive mechanical ventilation where oral medication is not allowed
5. Patients on long term macrolide treatment
6. Patients on macrolide as antibiotics for COPD exacerbation

Where this trial is running

Hong Kong

• Queen Mary Hospital — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Wang Chun Kwok, MBBS — Division of Respiratory Medicine, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong
• Study coordinator: Wang Chun Kwok, MBBS

Conditions: Chronic Obstructive Pulmonary Disease, N-acetylcysteine, Chronic Obstructive Pulmonary Disease exacerbation, Clinical trial