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Efficacy and safety of inhaled N-acetylcysteine on exacerbation of chronic obstructive pulmonary disease (AECOPD), a randomized controlled trial

Efficacy and safety of inhaled N-acetylcysteine on exacerbation of chronic obstructive pulmonary disease (AECOPD), a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007616
Enrollment
Unknown
Registered
2015-12-16
Start date
2016-01-01
Completion date
Unknown
Last updated
2017-04-18

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)

Interventions

A:Inhaled N-acetylcysteine 600 mg (300 twice a day)
B:Inhaled NS 6ml (3ml twice a day)

Sponsors

Affiliated Hospital of Chengdu University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients able to provide written informed consent and to fulfil study requests; 2. Outpatents, smoking or non-smoking, male or female; 3. Patients with a clinical diagnosis of COPD, post-bronchodilator FEV1/FVC <70%; 4. Diagnostic criteriameet the diagnostic criteria of Global Strategy For The Diagnosis, Management, And Prevention Of Chronic Obstructive Pulmonary Disease (Update 2014); 5. Patients with a history of at least two exacerbations within the previous two years and who are clinically stable for at least 4 weeks.

Exclusion criteria

Exclusion criteria: 1. Patients with a diagnosis of bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, pneumonia, bronchial pneumonia, bronchiectasis, lung cancer or lung metastases, other progressively fatal disease; 2. Patients with severe cardiovascular diseases, severe neurological diseases or severely impaired hepatic or renal function; 3. Patients taken inhaled corticosteroids or oral corticosteroids in the previous 1 month before hospitality entry; 4. Patients with any types of infection in precious 2 weeks; 5. Be allergy to study medications (N-acetylcysteine, NAC); 6. with reading or communication disorders; 7. Unsuitable for the study for every other reasons, in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Ros, Rp, Rc test by IOS;MDA, SOD;

Secondary

MeasureTime frame
Length of stay (LOS);modified medical british research council, mMRC score;SGRQ scale score;PCT, hs-CRP, IL-6, IL-8;

Countries

China

Contacts

Public ContactZhou Hui
zhouhuicdu@hotmail.com+86 13808004728

Outcome results

None listed

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