Latest news with #lungfunction
Medscape
22-05-2025
- Health
- Medscape
Exposure to Antibiotics Preterm May Affect Lung Function
Premature infants exposed to multiple courses of antibiotics around the time of birth had weaker lung function and a higher risk for asthma episodes by early school age than those with lower exposure. METHODOLOGY: The study analyzed 3820 premature infants born between 22 and 36 weeks of gestation with low birth weights (< 1500 g); the infants were enrolled from 58 hospitals across Germany over an 8-year period starting in January 2009. Researchers divided the infants into three groups: Low-risk, or those exposed via their mothers who were given surgical antimicrobial prophylaxis in the 30 minutes before delivery; intermediate-risk, or children exposed prenatally and after birth; and high-risk, or children who had been exposed within 7 days of delivery prenatally, again at 30 minutes prior to birth, and after birth. The primary outcome was the lung function and the amount of air each infant exhaled in the first second of forced exhalation, measured at ages 5-7 years. Secondary outcomes included the total amount of air exhaled or forced vital capacity and asthma episodes during childhood. The analysis included 3109 participants born by cesarean delivery, with 292 (9.4%) in the low-risk group, 1329 (42.7%) in the intermediate-risk group, and 1488 (47.9%) in the high-risk group. TAKEAWAY: Children with intermediate risk scores had poorer lung function than those with low risk scores, as shown by lower forced exhalation in one second outcomes (β, −0.31; 95% CI, −0.59 to −0.02; P = .03). = .03). Those with high-risk antibiotic exposure vs intermediate risk had lower forced vital capacity scores (β, −0.23; 95% CI, −0.43 to −0.03; P = .02). = .02). Children with the highest level of exposure to antibiotics had a higher risk for early childhood asthma episodes than those with intermediate risk (odds ratio, 1.91; 95% CI, 1.32-2.76; P = .001). IN PRACTICE: 'Early identification of high-risk neonates may enable targeted strategies to support respiratory health and optimize long-term outcomes,' the study authors wrote. SOURCE: The study was led by Ingmar Fortmann, MD, of the Department of Pediatrics at the University Hospital of Schleswig-Holstein at Campus Lübeck in Lübeck, Germany. It was published online on May 12 in JAMA Network Open . LIMITATIONS: The study had a low median follow-up rate that varied across clinics. The researchers did not have details on the dosage of antibiotics. Only children well enough to take lung function tests were included. Infants who received more antibiotics already had poor health status, which may have accounted for some of the findings. DISCLOSURES: One or more study authors reported receiving financial support fromthe Advanced Clinician Scientist Program and Section of Medicine at the University of Lübeck, personal fees from Chiesi, and grants from the German Federal Ministry of Education and Research. No other disclosures were reported.
Yahoo
16-05-2025
- Health
- Yahoo
Nuance Pharma Announces Ensifentrine Meets Primary Endpoint in Phase 3 ENHANCE-CHINA Trial for COPD
Statistically significant improvements in lung functionConsistent trends of quality of life and exacerbation rate reduction as ENHANCE-1/2Well tolerated safety profileNDA submission planned for 2H 2025 SHANGHAI, May 16, 2025 /PRNewswire/ -- Nuance Pharma ("Nuance") today announces its top-line Phase 3 ENHANCE-CHINA (NCT05743075) trial results evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease ("COPD"). The ENHANCE-CHINA trial has successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function. The investigational study drug, ensifentrine is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 ("PDE3; PDE4") that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination. Highlights - Study population (n = 526 randomized): Subject demographics and disease characteristics were well balanced between treatment groups Approximately 46% of subjects received background COPD therapy, either a long-acting muscarinic antagonist ("LAMA") or a long-acting beta-agonist ("LABA"). Additionally, approximately 38% of all subjects received inhaled corticosteroids ("ICS") with concomitant LABA. - Primary endpoint met (FEV1 AUC 0-12hr): Placebo corrected, change from baseline in average FEV1 area under the curve 0-12 hours post dose at week 12 was 110 mL (p<0.0001) for ensifentrine Statistically significant and clinically meaningful improvements with ensifentrine demonstrated across key subgroups including age, smoking status, COPD severity, background medication, ICS use, chronic bronchitis, FEV1 reversibility - Secondary endpoints of lung function: Placebo corrected, increase in peak FEV1 of 174 mL (p<0.0001) at week 12 Placebo corrected, increase in morning trough FEV1 of 36 ml (p=0.0533) and evening trough FEV1 of 65 ml (p=0.0038) at week 12, confirming twice daily dosing regimen. Placebo corrected, increase in average FEV1 of 162 ml (p<0.0001) 0-4 hours post dose and 77 mL (p=0.0003) 6-12 hours post dose at week 12 - COPD symptoms and quality of life (QoL): Clinically meaningful improvements in dyspnea as measured by Transition Dyspnea Index (TDI) in the ensifentrine group were observed at all weeks (6, 12 and 24) with a statistically significant improvement of 0.8 unit compared to placebo at week 24. Quality of Life (QoL) as measured by St George's Respiratory Questionnaire (SGRQ) Total Score in the ensifentrine group improved from baseline to greater than the MCID of -4 units with a significant improvement of -2.9 units compared to placebo at week 24. Daily symptoms as measured by Evaluating Respiratory Symptoms (E-RS) Total Score in ensifentrine group showed improvement from baseline as early as 6 weeks and continued improvement at 12 and 24 weeks, numerically exceeding placebo at each measurement. - Exacerbation rate reduced Subjects receiving ensifentrine demonstrated a 28% reduction in the rate of moderate/severe COPD exacerbations over 24 weeks compared to those receiving placebo (RR = 0.72, 95% CI: (0.43, 1.22)) Treatment with ensifentrine significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with placebo by 25% (HR = 0.75, 95% CI: (0.44, 1.28)) - Favorable safety profile: Ensifentrine was well-tolerated with treatment related AE incidence similar to placebo Mark Lotter, founder and Chief Executive Officer of Nuance Pharma, said:"We are very pleased by the successful outcome of our Phase 3 ENHANCE-CHINA study, bringining us another step closer to providing a much needed novel therapy for COPD patients in China. These promising results demonstrate ensifentrine's strength as a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD, as an advance to existing treatment options. We plan to submit a New Drug Application to the China NMPA in the second half of 2025. We would like to thank all the patients and investigators for their participation in the ENHANCE-CHINA program. " Charlie Chen, Chief Operating Officer of Nuance Pharma added:"The totality of ENHANCE data including improvements in lung function, symptoms, quality of life measure and reduction in exacerbations, coupled with favorable safety profile, support our belief that ensifentrine will change the treatment paradigm for COPD. Following our ongoing early access programs in Hainan BoAo and Greater Bay Area, as well as regulatory approval in Macau, we look forward to bringing this medicine to patients in Greater China." David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma, said:"we look forward to Nuance Pharma's continued progress and having Ohtuvayre® available for the millions of symptomatic patients needing additional treatment." Nuance Pharma plans to release additional information from ENHANCE-CHINA at upcoming scientific conferences. In Feb 2025, the Pharmaceutical Administration Bureau Macau approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD in adult patients. In Nov 2024, Nuance Pharma launched Ohtuvayre™ in China's Hainan Boao Pilot Zone through early access program. In Sep 2024, Nuance Pharma completed recruitment for ENHANCE-CHINA, the phase 3 clinical trial of Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD. In June 2024, Nuance Pharma's global partner Verona Pharma plc (Nasdaq: VRNA), announced the US Food and Drug Administration ("FDA") approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD in adult patients. In 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize Ohtuvayre™ (ensifentrine) in Greater China (mainland China, Hong Kong, Macau and Taiwan). About Ohtuvayre™ (ensifentrine)Ohtuvayre™ is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre™ in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance treatment. Ohtuvayre™ met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. About the ENHANCE-CHINA programThe randomized, double-blind, placebo-controlled study evaluate the efficacy and safety of nebulized ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA or a LABA, compared to placebo, and subjects may receive ICS. Patient Population: 526 moderate to severe, symptomatic, COPD patients at 46 sites in China. Dose/Duration: subjects were randomized to receive a 3mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 weeks Primary Endpoint: Improvement in lung function with ensifentrine as measured by average FEV1 AUC 0-12 hours post dose at week 12. Secondary Endpoints: lung function endpoints including peak and morning trough FEV1, COPD symptoms and health related quality of life through 24 weeks via SGRQ and E-RS, and exacerbation at 24 weeks, and others Safety: Assessed over 24 weeks Further information about ENHANCE-CHINA program can be found at (NCT05743075) About Verona PharmaVerona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre™ (ensifentrine) is the Company's first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ohtuvayre™ (ensifentrine) has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit About Nuance PharmaNuance Pharma is an innovation focused biopharmaceutical company, with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care, Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia. With the mission to address critical unmet medical needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline, while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information, please visit Forward-looking StatementsThis news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. View original content: SOURCE Nuance Pharma Limited
Gizmodo
15-05-2025
- Health
- Gizmodo
Lung Power Peaks in Our 20s—and It's a Steady Decline From There, Study Finds
Our lungs may start to lose their steam earlier in life than we thought. Research out today suggests that lung function tends to peak in young adulthood and only gets worse from there. Scientists at the Barcelona Institute for Global Health (ISGlobal) led the study, published Thursday in The Lancet Respiratory Medicine. After analyzing data from earlier population studies, the researchers found that peak lung function is usually reached by our early 20s and—contrary to current wisdom—continues to steadily decline as we age. According to lead author Judith Garcia-Aymerich, co-director of the Environment and Health over the Life Course program at ISGlobal, it's been assumed that our lungs follow a specific trajectory: they gradually get stronger until our mid-20s, reach a steady plateau over the next few decades, then decline as we reach middle age. But this assumption was based on studies that only examined lung function at certain time periods, rather than over the course of an entire life. To bridge this knowledge gap, Garcia-Aymerich's team combined and analyzed data from eight different population studies in Europe and Australia. These studies collectively involved around 30,000 people from the ages of four to 82, and lung function was measured through forced spirometry, a test where people blow out as much air as possible after taking a deep breath. The researchers first identified two broad stages of lung development: a phase of rapid growth in early childhood, followed by slower, steady growth through the early 20s. On average, this peak was reached around age 20 for women and age 23 for men. Unlike other research, they failed to find any evidence of a steady period of lung function following this peak. 'Previous models suggested a plateau phase until the age of 40, but our data show that lung function starts to decline much earlier than previously thought, immediately after the peak,' said Garcia-Aymerich in a statement released by ISGlobal. The findings, somber as they are, might help improve how respiratory health is tracked and maintained, the researchers say. They found that certain risk factors for poor lung health, such as asthma and smoking, might affect lung function a bit differently than suspected, for instance. Chronic asthma appears to weaken lung health at an early age, a weakness that then persists throughout a person's life. Smoking, on the other hand, seems to rapidly worsen a person's lungs starting in the mid-30s. Equipped with this knowledge, it might be possible to intervene early on, the researchers say. 'Early detection of low lung function may allow interventions to prevent chronic respiratory diseases in adulthood,' said Garcia-Aymerich. While our lungs might not stay in tip-top shape as long as hoped, there are things most anyone can do to keep them as healthy as possible, such as regular physical exercise.
Medscape
14-05-2025
- Health
- Medscape
Study Links Pre-COVID Lung Health to Severe COVID-19 Risk
In a large US cohort study, pre-pandemic severe obstructive lung function, as measured by spirometry, was linked to more than a twofold increased risk for severe COVID-19. METHODOLOGY: Researchers analyzed the association of pre-pandemic measures of lung function and structure with the risk for severe COVID-19 using data from 11 prospective US population-based cohorts. Overall, 29,323 participants (mean age, 67.1 years) with valid pre-pandemic lung function and incident COVID-19 data were followed up for a median of 17.3 months from March 1, 2020. Pre-pandemic spirometry data were used to classify lung function: Normal physiology (forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] ratio ≥ 0.70 and FVC ≥ 80% of the predicted value). Obstructive physiology (FEV1/FVC ratio < 0.70) and severe obstruction (FEV1 < 50% of the predicted value). Restrictive physiology (FEV1/FVC ratio ≥ 0.70 and FVC < 80% of the predicted value). Structural abnormalities, including emphysema and interstitial lung abnormalities such as lung distortion, honeycombing, traction bronchiectasis, nonemphysematous cysts, and ground-glass or reticular opacities, were assessed on CT scans. The primary outcome was severe COVID-19 (COVID-19 leading to hospitalization or death), and the secondary outcome was nonsevere COVID-19 (SARS-CoV-2 infection not requiring hospitalization). TAKEAWAY: Severe obstructive physiology and restrictive physiology were associated with an increased risk for severe COVID-19 compared with normal spirometry, with adjusted hazard ratios (aHRs) of 2.11 (95% CI, 1.36-3.27) and 1.40 (95% CI, 1.12-1.76), respectively. The risk for severe COVID-19 was 1.64-fold higher risk among those in the highest quartile than among those in the lowest quartile of percent emphysema (95% CI, 1.03-2.61). Higher pre-pandemic FEV1 and FVC levels and being in the highest quartile of percent high attenuation areas (indicative of interstitial lung disease) were associated with an increased risk for nonsevere COVID-19. COVID-19 vaccination was associated with a reduced risk for severe disease across all lung function and structure categories (aHR, 0.19-0.50; P for interaction > .30). IN PRACTICE: 'These findings support enhanced COVID-19 risk mitigation, including COVID-19 vaccination, for individuals with impaired lung health,' the authors wrote. SOURCE: This study was led by Pallavi P. Balte, MBBS, PhD, Division of General Medicine, Columbia University Irving Medical Center, New York City. It was published online on April 16, 2025, in American Journal of Respiratory and Critical Care Medicine . LIMITATIONS: This study primarily collected data during the pre-Omicron period, limiting the generalizability of the findings to current variants. Additionally, some cohort studies recruited participants who were healthier than average, while others oversampled individuals with disease, affecting population representativeness. DISCLOSURES: This study was supported by a grant from the National Heart, Lung, and Blood Institute; reported receiving co-funding from the National Institute of Neurological Disorders and Stroke and the National Institute on Aging; and reported receiving additional funding from the American Lung Association. Six authors reported having financial ties with various pharmaceutical companies and research organizations.
