Dataset Information

The clinical efficacy of AG NPP709 (Synatura^®) in patients with chronic bronchitis type stable chronic obstructive pulmonary disease.

ABSTRACT:

Background

AG NPP709 (Synatura^®) has been demonstrated to be efficacious in decreasing cough and sputum in patients with acute upper respiratory infection and chronic inflammatory bronchitis. The aim of this study was to evaluate the efficacy of AG NPP709 in patients with chronic bronchitis type chronic obstructive pulmonary disease (COPD).

Methods

This was a prospective, open-label, single-arm clinical trial (NCT03623282). Chronic bronchitis type COPD patients aged >40 years were enrolled. The primary endpoint was improvement on the CAT scores between the baseline visit and week 12. The secondary endpoints were the effect of AG NPP709 on the pulmonary function and systemic inflammation, as indexed by CRP, fibrinogen, IL-6, TNF-α and IL-33 levels.

Results

Thirty patients were enrolled. All patients were male, and their mean age was 71.93±7.93 years. The mean post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio was 58.63±11.40, and FEV1 (%) was 75.93±20.42. The mean total CAT score was 14.77±7.14. Of these patients, 26 were followed up after 3 months. A significant improvement was observed in the total CAT score (from 14.38±6.62 to 12.73±6.60, P=0.005). Fibrinogen level decreased significantly (P=0.013). No serious adverse events occurred.

Conclusions

AG NPP709 improved the quality of life, as represented by the CAT score, in patients with chronic bronchitis type COPD, and significantly reduced fibrinogen levels. These results suggest that AG NPP709 is efficacious and safe in patients with chronic bronchitis type COPD.

SUBMITTER: Lee EG

PROVIDER: S-EPMC7330415 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Publications

The clinical efficacy of AG NPP709 (Synatura<sup>®</sup>) in patients with chronic bronchitis type stable chronic obstructive pulmonary disease.

Lee Eung Gu EG Rhee Chin Kook CK

Journal of thoracic disease 20200501 5

<h4>Background</h4>AG NPP709 (Synatura<sup>®</sup>) has been demonstrated to be efficacious in decreasing cough and sputum in patients with acute upper respiratory infection and chronic inflammatory bronchitis. The aim of this study was to evaluate the efficacy of AG NPP709 in patients with chronic bronchitis type chronic obstructive pulmonary disease (COPD).<h4>Methods</h4>This was a prospective, open-label, single-arm clinical trial (NCT03623282). Chronic bronchitis type COPD patients aged >40 ...[more]

PMID: 32642149

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Project description:BackgroundChronic obstructive pulmonary disease (COPD) remains a major cause of morbidity and mortality. Present-day diagnostic criteria are largely based solely on spirometric criteria. Accumulating evidence has identified a substantial number of individuals without spirometric evidence of COPD who suffer from respiratory symptoms and/or increased morbidity and mortality. There is a clear need for an expanded definition of COPD that is linked to physiologic, structural (computed tomography [CT]) and clinical evidence of disease. Using data from the COPD Genetic Epidemiology study (COPDGene®), we hypothesized that an integrated approach that includes environmental exposure, clinical symptoms, chest CT imaging and spirometry better defines disease and captures the likelihood of progression of respiratory obstruction and mortality.MethodsFour key disease characteristics - environmental exposure (cigarette smoking), clinical symptoms (dyspnea and/or chronic bronchitis), chest CT imaging abnormalities (emphysema, gas trapping and/or airway wall thickening), and abnormal spirometry - were evaluated in a group of 8784 current and former smokers who were participants in COPDGene® Phase 1. Using these 4 disease characteristics, 8 categories of participants were identified and evaluated for odds of spirometric disease progression (FEV1 > 350 ml loss over 5 years), and the hazard ratio for all-cause mortality was examined.ResultsUsing smokers without symptoms, CT imaging abnormalities or airflow obstruction as the reference population, individuals were classified as Possible COPD, Probable COPD and Definite COPD. Current Global initiative for obstructive Lung Disease (GOLD) criteria would diagnose 4062 (46%) of the 8784 study participants with COPD. The proposed COPDGene® 2019 diagnostic criteria would add an additional 3144 participants. Under the new criteria, 82% of the 8784 study participants would be diagnosed with Possible, Probable or Definite COPD. These COPD groups showed increased risk of disease progression and mortality. Mortality increased in patients as the number of their COPD characteristics increased, with a maximum hazard ratio for all cause-mortality of 5.18 (95% confidence interval [CI]: 4.15-6.48) in those with all 4 disease characteristics.ConclusionsA substantial portion of smokers with respiratory symptoms and imaging abnormalities do not manifest spirometric obstruction as defined by population normals. These individuals are at significant risk of death and spirometric disease progression. We propose to redefine the diagnosis of COPD through an integrated approach using environmental exposure, clinical symptoms, CT imaging and spirometric criteria. These expanded criteria offer the potential to stimulate both current and future interventions that could slow or halt disease progression in patients before disability or irreversible lung structural changes develop.

Project description:BackgroundChronic bronchitis (CB) is associated with poor outcomes in patients with chronic obstructive pulmonary disease. The aim of this study was to identify the characteristics that distinguish chronic bronchitis (CB) from non-CB. In addition, the features of mild CB versus severe CB were compared and a cut-off level was defined according to CAT1 and CAT2 scores.MethodsThis study was based on the Korea COPD Subgroup Study (KOCOSS) database, constructed in a multicenter COPD cohort study that recruited patients from 54 centers. CB was defined as CAT1 and CAT2 scores ≥ 3; severe CB was defined as CAT1 and CAT2 scores ≥ 4, while mild CB was defined as either a CAT1 or a CAT2 score < 4. Baseline characteristics, 1-year exacerbation rate, and 3-year FEV1 decline were compared in non-CB versus CB patients and in patients with mild CB versus severe CB.ResultsAmong the 2162 patients enrolled in this study, 497 (23%) had CB. These patients were more likely than non-CB patients to be current smokers; they also had higher symptom and depression/anxiety scores. Lung function tests showed lower FEV1, FEV1/FVC, and DLco values in CB patients. Among CB patients, 67.6% had mild disease. Symptom and depression/anxiety scores were worse in patients with severe CB than in patients with mild CB. There were no significant differences in the lung function tests of the two groups. Analysis of 1-year exacerbation rates in CB patients and non-CB patients revealed that patients with CB more frequently had moderate-to-severe exacerbations (OR = 1.46, p < 0.01). More severe exacerbation was also present in patients with severe CB than in patients with mild CB (OR = 2.52, p = 0.01). The difference in annual FEV1 decline rate did not significantly differ either between CB patients and non-CB patients or between patients with severe CB and patients with mild CB.ConclusionsCB patients had worse symptoms and lung function than non-CB patients; CB patients also had more frequent moderate-to-severe exacerbation. Patients with severe CB had higher symptom scores and more frequent severe exacerbation than did patients with mild CB.

Dataset Information

The clinical efficacy of AG NPP709 (Synatura^®) in patients with chronic bronchitis type stable chronic obstructive pulmonary disease.

Background

Methods

Results

Conclusions

Publications

The clinical efficacy of AG NPP709 (Synatura<sup>®</sup>) in patients with chronic bronchitis type stable chronic obstructive pulmonary disease.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

The clinical efficacy of AG NPP709 (Synatura®) in patients with chronic bronchitis type stable chronic obstructive pulmonary disease.

Background

Methods

Results

Conclusions

Publications

The clinical efficacy of AG NPP709 (Synatura<sup>®</sup>) in patients with chronic bronchitis type stable chronic obstructive pulmonary disease.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

The clinical efficacy of AG NPP709 (Synatura^®) in patients with chronic bronchitis type stable chronic obstructive pulmonary disease.