Trial reportInternational journal of chronic obstructive pulmonary disease2016
High-dose oral N-acetylcysteine fails to improve respiratory health status in patients with chronic obstructive pulmonary disease and chronic bronchitis: a randomized, placebo-controlled trial.
Trial report in International journal of chronic obstructive pulmonary disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01739790 (Effects of High-Dose N-Acetylcysteine on Respiratory Health Status in Patients With Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 24 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of High-Dose N-Acetylcysteine on Respiratory Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis: A Randomized, Placebo-Controlled Trial-3
Who cites it
24 citing papers in PubMed, 5 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Efficacy and safety of mucolytic agents in patients with chronic obstructive pulmonary disease: a systematic review and network meta-analysis.BMC pulmonary medicine · 2026Pooled it
- Pooled it
- Tailored or adapted interventions for adults with chronic obstructive pulmonary disease and at least one other long-term condition: a mixed methods review.The Cochrane database of systematic reviews · 2021Pooled it
- Mucolytic agents versus placebo for chronic bronchitis or chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2019Pooled it
- The efficacy ofTherapeutic advances in respiratory diseasePooled it
- Effect of Erdosteine on COPD Exacerbations in COPD Patients with Moderate Airflow Limitation.International journal of chronic obstructive pulmonary disease · 2019Trial
- The Impacts of Dengue Virus Infection on Mitochondrial Functions and Dynamics.International journal of molecular sciences · 2025Review
- Advances in the Use ofAntioxidants (Basel, Switzerland) · 2023Review
- Use of thiols and implications for the use of inhaled corticosteroids in the presence of oxidative stress in COPD.Respiratory research · 2023Review
- Pathological Mechanism and Targeted Drugs of COPD.International journal of chronic obstructive pulmonary disease · 2022Review
- The Role of Oxidative Stress in Sarcoidosis.International journal of molecular sciences · 2021Review
- The antioxidant N-acetylcysteine promotes immune response and inhibits epithelial-mesenchymal transition to alleviate pulmonary fibrosis in chronic obstructive pulmonary disease by suppressing the VWF/p38 MAPK axis.Molecular medicine (Cambridge, Mass.) · 2021Article
- Review
- Safety of N-Acetylcysteine at High Doses in Chronic Respiratory Diseases: A Review.Drug safety · 2021Review
- N-Acetylcysteine Reverses Antiretroviral-Mediated Microglial Activation by Attenuating Autophagy-Lysosomal Dysfunction.Frontiers in neurology · 2020Article
- Nitric oxide-releasing alginates as mucolytic agents.ACS biomaterials science & engineering · 2019Article
- Medical and Dietary Uses of N-Acetylcysteine.Antioxidants (Basel, Switzerland) · 2019Review
- Scientific Papers and Patents on Substances with Unproven Effects. Part 2.Recent patents on drug delivery & formulation · 2019Review
- Medication Regimens for Managing COPD Exacerbations.Respiratory care · 2018Review
- Mechanisms and consequences of oxidative stress in lung disease: therapeutic implications for an aging populace.American journal of physiology. Lung cellular and molecular physiology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinical outcomes are worse in patients with COPD and chronic bronchitis. N-acetylcysteine (NAC) is commonly prescribed for such patients but with uncertain clinical benefits. We postulated that oral NAC, at much larger doses than those ordinarily prescribed, would improve clinical outcomes in a subset of patients with COPD and chronic bronchitis.
objectiveThe aim of this study was to determine whether very high-dose NAC would improve respiratory health status in patients with COPD and chronic bronchitis.
methodsPatients with COPD and chronic bronchitis were enrolled in a randomized, controlled, double-blinded trial. Patients received oral NAC (1,800 mg) or matching placebo twice daily for 8 weeks in addition to their usual respiratory medications. The primary outcome, respiratory health status, was assessed by changes in the St George's Respiratory Questionnaire. The effects of NAC on lung function and circulating markers of oxidative stress and inflammation were also evaluated.
resultsWe terminated the study prematurely because new external information suggested the possibility of a safety issue. Of the planned 130 patients, 51 were randomized and 45 (22 in the placebo arm and 23 in the NAC arm) completed the study. There was no statistically significant difference between changes in the St George's Respiratory Questionnaire total score, comparing NAC to placebo (adjusted mean difference, 0.1 U; 95% CI, -7.8 to 8.18 U; P=0.97). There were also no significant NAC-related improvements in any of the secondary outcomes.
conclusionIn this 8-week trial, we were unable to show any clinical benefit from a very high dose of NAC in patients with COPD and chronic bronchitis.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.