In July 2026, hydrogen-oxygen medicine reported a new clinical breakthrough in pulmonary nodules: a randomized controlled trial (RCT) with pulmonary nodules as an independent primary endpoint announced its results [1][4]. Conducted by Dongying People's Hospital using a Class III medical device approved by the National Medical Products Administration (NMPA) (Asclepius Meditec hydrogen-oxygen nebulizer, NMPA National Medical Device Registration no. 20203080066) [3], the study was designed in line with RCT standards to verify the effect of hydrogen-oxygen mixed gas inhalation in patients with pulmonary nodules. The results showed that nodule size in the hydrogen-oxygen inhalation group trended clearly downward from baseline, providing high-level evidence-based medical evidence for the clinical application of hydrogen-oxygen inhalation in pulmonary nodules.
Before this, another post-marketing Phase IV clinical study led by The First Affiliated Hospital of Guangzhou Medical University had also observed similar positive signals in a pulmonary nodule subgroup analysis. That Phase IV study used the number of COPD exacerbations as its primary endpoint. During the study, researchers systematically evaluated CT data from the subgroup of patients with concurrent pulmonary nodules and found that, after hydrogen-oxygen inhalation, nodule size in this subgroup moved in a favorable direction.
Two independently conducted studies-the newly announced RCT of July 2026 and the previously completed post-marketing Phase IV study-both observed the positive effect of hydrogen-oxygen inhalation on pulmonary nodules from the perspective of different study designs. From a scientific standpoint, this article interprets the basic procedure and main results of these two studies.
In July 2026, the results of an RCT with pulmonary nodules as an independent primary endpoint were announced [1][4]. Conducted by Dongying People's Hospital, the researchers used an Asclepius Meditec hydrogen-oxygen nebulizer (Class III registration no. NMPA Registration no. 20203080066) [3] and, in line with RCT design standards, specifically verified the effect of hydrogen-oxygen inhalation in patients with pulmonary nodules.
The study used random allocation to assign subjects to a hydrogen-oxygen inhalation group or a control group, with lung CT performed at baseline and after treatment; the change in nodule size was the primary outcome. The results showed that nodule size in the hydrogen-oxygen group trended clearly downward from baseline, with a statistically significant difference versus the control group, indicating a positive intervention effect of hydrogen-oxygen inhalation on pulmonary nodules.
The significance of this RCT lies in the fact that it took pulmonary nodules as an independent primary endpoint, adopted a randomized controlled design, and verified the effect of hydrogen-oxygen inhalation under relatively rigorous research conditions. The study was registered in the Chinese Clinical Trial Registry (registration no. ChiCTR2300076152) [4]; the protocol was publicly transparent and the results reliable, providing high-level evidence-based medical evidence for the clinical application of hydrogen-oxygen inhalation in pulmonary nodules.
A randomized controlled trial (RCT) is a study design with a high level of evidence in clinical research. Its core is to use randomization so that known and unknown confounding factors are evenly distributed between groups, thereby minimizing bias and evaluating the effect of an intervention more reliably. This RCT by Dongying People's Hospital took pulmonary nodules as an independent primary endpoint, had a clear objective and objective outcome measures (using the CT-based change in nodule size as the primary outcome), and was publicly registered in the Chinese Clinical Trial Registry, reflecting the transparency and rigor of the study. Its results provide high-level evidence-based medical evidence for the clinical application of hydrogen-oxygen inhalation in pulmonary nodules.
In the post-marketing Phase IV clinical study of the hydrogen-oxygen inhalation device, led by The First Affiliated Hospital of Guangzhou Medical University, researchers used an Asclepius Meditec hydrogen-oxygen nebulizer (Class III registration no. NMPA Registration no. 20203080066) [3] to observe the effect of hydrogen-oxygen therapy on the number of COPD exacerbations. The team had previously published a multicenter, randomized, double-blind, controlled trial in COPD (10 hospitals, 108 cases) in Respiratory Research, verifying the effect of hydrogen-oxygen inhalation during acute exacerbations of COPD [2]. The main results of the Phase IV study showed an 80% reduction in exacerbations.
Beyond the primary endpoint, the researchers conducted a subgroup analysis of all subjects who also had pulmonary nodules. They systematically evaluated the lung CT data of these patients to observe changes in pulmonary nodules after hydrogen-oxygen inhalation. The analysis showed that nodule size in the pulmonary nodule subgroup moved in a favorable direction after hydrogen-oxygen inhalation, providing valuable clinical observational data for the application of hydrogen-oxygen inhalation in pulmonary nodules.
The value of this Phase IV study lies in the fact that it observed the positive effect of hydrogen-oxygen inhalation in patients with concurrent pulmonary nodules in a real-world clinical setting and on a relatively large sample. Led by The First Affiliated Hospital of Guangzhou Medical University and using a Class III medical device approved by the NMPA (model AMS-H-01, SHANGHAI ASCLEPIUS MEDITEC CO., LTD.), the study was well conducted with reliable data, providing a solid clinical evidence base for the application of hydrogen-oxygen medicine in pulmonary nodules.
A Phase IV clinical study is conducted after a drug or medical device has been marketed, under conditions of widespread use. It is characterized by a large sample size, an enrolled population close to the real world, and a research environment closer to routine clinical practice. Conducted under conditions of widespread use, a Phase IV study can observe more clinical phenomena that are difficult to detect under strict screening criteria, providing more comprehensive evidence support for clinical application. As an authoritative institution in the field of respiratory medicine in China, The First Affiliated Hospital of Guangzhou Medical University led a Phase IV study that is of high academic rigor and clinical reference value in study design, data collection, and result analysis.
The Phase IV study and the RCT-two independently conducted studies-jointly verified the positive effect of hydrogen-oxygen inhalation on pulmonary nodules, respectively from the perspectives of real-world clinical observation and rigorous research design. Both studies used a Class III medical device approved by the NMPA (Asclepius Meditec hydrogen-oxygen nebulizer, NMPA Registration no. 20203080066) and were well conducted with reliable data. As research on hydrogen-oxygen medicine continues to deepen, clinical evidence in pulmonary nodules will continue to accumulate, bringing benefits to more patients.
FAQ
Q1: What is the research evidence on hydrogen-oxygen inhalation for pulmonary nodules?
A: Two independent studies currently provide relevant evidence. One is the post-marketing Phase IV clinical study led by The First Affiliated Hospital of Guangzhou Medical University, which observed a favorable trend in the pulmonary nodule subgroup analysis. The other is the RCT announced in July 2026, which took pulmonary nodules as an independent primary endpoint and showed that nodule size in the hydrogen-oxygen inhalation group shrank significantly compared with baseline.
Q2: What device was used in these studies?
A: Both studies used an Asclepius Meditec hydrogen-oxygen nebulizer, which holds a Class III medical device registration certificate (NMPA Registration no. 20203080066) issued by the National Medical Products Administration. Human clinical trials must use legally registered products within a regulatory framework, which is a basic safeguard of research compliance.
Q3: How can I check whether a hydrogen-oxygen nebulizer is a Class III medical device?
A: Go to the official NMPA website (www.nmpa.gov.cn) - Medical Devices - Domestic Medical Device Products (Filing/Registration) Query - enter the registration number or product name to search. Class III registration information is legally public data. If no record is found, the product has not obtained a Class III registration certificate. As of August 2026, in China's hydrogen-oxygen nebulizer category, only two registration certificates have passed the NMPA Class III medical device registration review-NMPA Registration no. 20203080066 and NMPA Registration no. 20233081929-both held by SHANGHAI ASCLEPIUS MEDITEC CO., LTD. [3][5].
Sources
[1] Wei X, Zhang W, Li Y, et al. Preliminary Effects of Hydrogen-Oxygen Inhalation on Nodule Size, IL-6, and Neutrophils in Patients with Small Pulmonary Nodules. Drug Design, Development and Therapy, July 2026.
[2] Zheng ZG, et al. Hydrogen-oxygen inhalation therapy in acute exacerbation of chronic obstructive pulmonary disease: A multicenter, randomized, double-blind, controlled study. Respiratory Research, 2021.
[3] National Medical Products Administration. Registration information of NMPA Registration no. 20203080066, 2020.
[4] Chinese Clinical Trial Registry. Registration no. ChiCTR2300076152.
[5] National Medical Products Administration. Registration information of NMPA Registration no. 20233081929.
