Pulmonary TherapyPub Date : 2023-03-01DOI: 10.1007/s41030-022-00207-7
Stephanie Lovinsky-Desir, Anna Volerman
{"title":"Applying Lessons from the COVID-19 Pandemic to Improve Pediatric Asthma Care.","authors":"Stephanie Lovinsky-Desir, Anna Volerman","doi":"10.1007/s41030-022-00207-7","DOIUrl":"https://doi.org/10.1007/s41030-022-00207-7","url":null,"abstract":"<p><p>Asthma is the most common chronic childhood condition and is a risk factor for severe respiratory viral infections. Thus, early during the coronavirus disease 2019 (COVID-19) pandemic there was concern that children with asthma would be at risk for severe COVID-19 illness and that asthma control could worsen as a result of the pandemic. This article seeks to summarize what was learned in the early stages of the pandemic about the impact of COVID-19 on children with asthma. We review evidence from several studies that demonstrated a significant decline in asthma morbidity in the first year of the pandemic. Additionally, we describe several potential mechanisms that may explain the reduced frequency in childhood asthma exacerbations as well as review lessons learned for future management of childhood asthma. While the COVID-19 pandemic initially brought uncertainty, it soon became clear that the pandemic had several positive effects for children with asthma. Now we can apply the lessons that were learned during the pandemic to re-examine asthma care practices as well as advocate for best approaches for asthma management.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/00/3f/41030_2022_Article_207.PMC9707220.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9462220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pulmonary TherapyPub Date : 2023-03-01DOI: 10.1007/s41030-022-00208-6
Andrew Li, Pyng Lee
{"title":"Which Endoscopic Procedure to Use and in What Patient? Valves, Coils, Foam, and Heat in COPD and Asthma.","authors":"Andrew Li, Pyng Lee","doi":"10.1007/s41030-022-00208-6","DOIUrl":"https://doi.org/10.1007/s41030-022-00208-6","url":null,"abstract":"<p><p>Despite the latest developments in therapeutic agents targeting airway endotypes, a significant proportion of patients with asthma and chronic obstructive pulmonary disease (COPD) remain symptomatic. Endoscopic therapies have a complementary role in the management of these airway diseases. The sustained efficacy of bronchial thermoplasty (BT) among patients with asthma over 10 years has been encouraging, as it has been shown to improve symptom control and reduce hospital admissions and exacerbations. Studies suggest that BT helps ameliorate airway inflammation and reduce airway smooth muscle thickness. While studies suggest that it is as effective as biologic agents, its role in the management of severe asthma has yet to be clearly defined and GINA 2022 still suggests limiting its use to patients with characteristics of the various populations studied. Conversely, bronchoscopic lung volume reduction has shown promise among patients with advanced COPD. Rigorous patient selection is important. Patients with minimal collateral ventilation (CV) and higher heterogeneity index have shown to benefit the most from endobronchial valve (EBV) therapy. For those with ongoing CV, endobronchial coils would be more appropriate. Both therapeutic modalities have demonstrated improved quality of life, effort tolerance, and lung function indices among appropriately selected patients. The emerging evidence suggests that endoscopic procedures among airway disease still have a substantial role to play despite the development of new therapeutic options.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e6/54/41030_2022_Article_208.PMC9931990.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10737618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pulmonary TherapyPub Date : 2023-03-01DOI: 10.1007/s41030-022-00210-y
Graham F Hatfull
{"title":"Phage Therapy for Nontuberculous Mycobacteria: Challenges and Opportunities.","authors":"Graham F Hatfull","doi":"10.1007/s41030-022-00210-y","DOIUrl":"https://doi.org/10.1007/s41030-022-00210-y","url":null,"abstract":"<p><p>Non-tuberculous mycobacterium (NTM) infections are often clinically challenging, with lengthy antibiotic regimens that fail to resolve the infections with few good outcomes remaining. Mycobacteriophages-viruses that infect Mycobacterium hosts-show promise as therapeutic agents for NTM infections and have been used in 20 compassionate use cases. Favorable outcomes were observed in many but not all cases, although the phages show exceptional safety profiles and no evidence of phage resistance was observed, even when only a single phage was administered. Phage-specific antibodies are commonly present following intravenous administration and are often neutralizing for the phage in vitro. However, phage neutralization does not consistently correlate with poor treatment outcomes and may not be a therapeutic limitation in all patients, even when immunocompetent. Currently, the therapeutic potential of phages is substantially limited by the great variation in phage susceptibility and a relatively small repertoire of therapeutically useful phages. As many as 45% of clinical isolates can have a smooth colony morphotype, and phages that both efficiently infect and kill these strains have yet to be described. In contrast, ~ 75% of rough strains are susceptible to and killed by one or more phages and therapeutic options can be considered on a compassionate use basis. Although therapies must currently be personalized, elucidating the determinants of phage host specificity, expanding the useful phage repertoire, and identifying the key determinants of clinical outcomes will reveal their full therapeutic potential.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/16/a4/41030_2022_Article_210.PMC9931961.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10740985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pulmonary TherapyPub Date : 2022-12-01DOI: 10.1007/s41030-022-00203-x
Alan G Kaplan, James W Kim
{"title":"Asthma Exacerbations and Glucagon-Like Peptide-1 Receptor Agonists: a Review of the Current Evidence.","authors":"Alan G Kaplan, James W Kim","doi":"10.1007/s41030-022-00203-x","DOIUrl":"https://doi.org/10.1007/s41030-022-00203-x","url":null,"abstract":"<p><p>Asthma is a chronic inflammatory disease involving multiple mediators and cytokines. While our current treatments have shown significant therapeutic benefits, there still appear to be some patients who, despite aggressive therapy, good adherence, and inhaler technique, continue to have exacerbations. Exacerbations lead to loss of lung function, exposure to systemic corticosteroids, effects on quality of life, and even mortality. There is a large number of glucagon-like peptide-1 (GLP-1) receptors in the lung even compared with other organs, and studies have shown evidence of reduced exacerbations in asthmatics treated with GLP-1 receptor agonists (GLP-1 RA). While weight loss may affect lung mechanics, evidence of inflammatory changes has been revealed that could explain this relationship. This article will review the data behind these conjectures and outline potential clinical utility and the need for future studies to truly understand the role of GLP-1 receptors in the lung.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/83/d5/41030_2022_Article_203.PMC9727043.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10373160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pulmonary TherapyPub Date : 2022-12-01Epub Date: 2022-11-01DOI: 10.1007/s41030-022-00201-z
Lilla Tamási, Anna Bartha, Aranka Ferencz, Mihály Tímár, Mikko Vahteristo, Aino Takala, Veronika Müller
{"title":"Effectiveness and Treatment Compliance of Salmeterol-Fluticasone Easyhaler<sup>®</sup> Among Patients with Asthma, COPD, or Asthma-COPD Overlap Syndrome: Real-World Study Findings.","authors":"Lilla Tamási, Anna Bartha, Aranka Ferencz, Mihály Tímár, Mikko Vahteristo, Aino Takala, Veronika Müller","doi":"10.1007/s41030-022-00201-z","DOIUrl":"10.1007/s41030-022-00201-z","url":null,"abstract":"<p><strong>Introduction: </strong>For inhalation therapies to be effective, it is crucial that patients manage inhaler use correctly in their everyday life and achieve treatment compliance. We investigated the effectiveness of the salmeterol-fluticasone propionate Easyhaler<sup>®</sup> (SF EH) device-metered dry powder inhaler in a real-world setting in Hungary among adult patients with asthma, chronic obstructive pulmonary disease (COPD), or asthma-COPD overlap syndrome (ACO).</p><p><strong>Methods: </strong>A prospective, open-label, multicenter, noninterventional, investigator-sponsored study was conducted in outpatient pneumonology centers. Eligible patients were aged ≥ 18 years with either a new diagnosis of asthma, COPD, or ACO, or whose disease was not controlled with preexisting medication. Data were collected at baseline and 12 + 4 weeks, including the asthma control test (ACT), COPD assessment test (CAT), spirometry parameters [including forced expiratory volume for 1 s (FEV<sub>1</sub>)], and physician- and patient-reported outcomes.</p><p><strong>Results: </strong>Five hundred sixteen patients were recruited from 103 centers: 376 with asthma; 104 with COPD; and 36 with ACO. At week 12, there were significant improvements from baseline in both mean ACT score in patients with asthma (14.4 ± 4.2 versus 21.4 ± 2.8; P < 0.001) and mean CAT score in patients with COPD (24.0 ± 6.1 versus 16.0 ± 5.8; P < 0.001). Significant improvement was observed when the switch from the most frequently used previous inhalers was analyzed separately. Mean FEV<sub>1</sub> improved from 76.0% ± 17.2 to 84.7% ± 16.1 (P < 0.001) and from 53.8% ± 15.0 to 59.9% ± 15.0 (P < 0.001) in patients with asthma or COPD, respectively. The study demonstrated improved physician-rated overall treatment compliance and patient preference for the SF EH over 3 months use compared with previous inhaler treatment, with patients effectively adopting the SF EH into everyday life.</p><p><strong>Conclusions: </strong>Treatment with SF EH significantly improved patients' lung function parameters and disease control.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/22/3d/41030_2022_Article_201.PMC9628494.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10736387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pulmonary TherapyPub Date : 2022-12-01DOI: 10.1007/s41030-022-00200-0
Takako Nagai, Hiroshi Uei, Kazuyoshi Nakanishi
{"title":"Relationship Between Start of Feeding and Functional Outcome in Aspiration Pneumonia: A Retrospective Cohort Study.","authors":"Takako Nagai, Hiroshi Uei, Kazuyoshi Nakanishi","doi":"10.1007/s41030-022-00200-0","DOIUrl":"https://doi.org/10.1007/s41030-022-00200-0","url":null,"abstract":"<p><strong>Introduction: </strong>Aspiration pneumonia is the predominant form of pneumonia in the elderly. Low oral intake levels and malnutrition have been reported to be associated with increased mortality and loss of function in aspiration pneumonia. However, the relationship between start of feeding and readmission, which is associated with malnutrition and low oral intake levels, has not been reported. The purpose of this study was to clarify the relationship between start of feeding and functional prognosis in aspiration pneumonia.</p><p><strong>Methods: </strong>Patients' basic information, comorbidities, severity of pneumonia, swallowing function, time from admission to the start of feeding, geriatric nutritional risk index (GNRI), readmission, and Barthel index (BI) were evaluated in 160 patients. The patients were divided into two groups-a readmission group and a non-readmission group-and statistical verification was performed.</p><p><strong>Results: </strong>The readmission group was 62 cases (38.8%). Univariate analysis showed that the time from admission to the start of feeding was significantly longer in the readmission group (p < 0.001). Age was significantly higher and nutrition parameters were lower in the readmission group (p = 0.001, 0.006). Furthermore, according to logistic regression analysis, readmission was associated with age (odds ratio, 1.063; p = 0.007; 95% confidence interval (CI) 1.017-1.111) and time from admission to the start of feeding (odds ratio 1.080; p < 0.001; 95% CI 1.025-1.137).</p><p><strong>Conclusion: </strong>The time from admission to the start of feeding was significantly longer in the readmitted patients. A comprehensive intervention with multidisciplinary collaboration should be performed from the early stage of hospitalization.</p><p><strong>Trial registration: </strong>This study is registered in the UMIN-Clinical Trials Registry (UMIN-CTR). UMIN-CTR meets the criteria of the International Committee of Medical Journal Editors (ICMJE). (Registration number: 000047141).</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2d/2f/41030_2022_Article_200.PMC9727170.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10367503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pulmonary TherapyPub Date : 2022-12-01DOI: 10.1007/s41030-022-00202-y
Gregory S Sawicki, Michael W Konstan, Edward F McKone, Richard B Moss, Barry Lubarsky, Ellison Suthoff, Stefanie J Millar, David J Pasta, Nicole Mayer-Hamblett, Christopher H Goss, Wayne J Morgan, Margaret E Duncan, Yoojung Yang
{"title":"Rate of Lung Function Decline in People with Cystic Fibrosis Having a Residual Function Gene Mutation.","authors":"Gregory S Sawicki, Michael W Konstan, Edward F McKone, Richard B Moss, Barry Lubarsky, Ellison Suthoff, Stefanie J Millar, David J Pasta, Nicole Mayer-Hamblett, Christopher H Goss, Wayne J Morgan, Margaret E Duncan, Yoojung Yang","doi":"10.1007/s41030-022-00202-y","DOIUrl":"https://doi.org/10.1007/s41030-022-00202-y","url":null,"abstract":"<p><strong>Introduction: </strong>Cystic fibrosis (CF) is an autosomal recessive disease caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. Approximately 5% of people with CF have residual function (RF) CFTR mutations that result in partially retained CFTR activity. Published literature on disease trajectory among those with RF mutations is limited. In this retrospective study, we characterized lung function decline across different age groups in CFTR modulator-untreated people with CF heterozygous for F508del and an RF mutation (F/RF).</p><p><strong>Methods: </strong>Rate of decline in percent predicted forced expiratory volume in 1 s (ppFEV<sub>1</sub>) was analyzed using data from the US CF Foundation Patient Registry (2006-2014) in F/RF (all), F/RF (excluding R117H), and F508del homozygous (F/F) cohorts. Annual rates of ppFEV<sub>1</sub> decline were estimated over 2-year periods based on calendar year. Subgroup analyses by age [6-12 (children), 13-17 (adolescents), 18-24 (young adults), and ≥ 25 years (adults)] were performed.</p><p><strong>Results: </strong>The estimated annualized rate of ppFEV<sub>1</sub> decline was - 0.70 percentage points per year (95% CI -1.09, -0.30) in the F/RF (all) cohort (N = 1242) versus -1.91 percentage points per year (95% CI -2.01, -1.80) in the F/F cohort (N = 11,916) [difference, 1.29 percentage points per year (95% CI 0.88, 1.70); P < 0.001]. In the F/RF (all) cohort, all age groups demonstrated lung function decline ranging from -0.30 to -1.38. In the F/RF (excluding R117H) cohort, the rate of decline was -1.05 percentage points per year (95% CI -1.51, -0.60) [difference versus F/F cohort, 0.95 percentage points per year (95% CI 0.48, 1.41; P < 0.001); not statistically significant in children and young adults].</p><p><strong>Conclusion: </strong>Progressive lung function decline was observed in people with F/RF genotypes across all assessed age groups, reinforcing the importance of early intervention and clinical monitoring to preserve lung function in all people with CF.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a1/f1/41030_2022_Article_202.PMC9727051.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9276818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pulmonary TherapyPub Date : 2022-09-01DOI: 10.1007/s41030-022-00195-8
Benjamin Pippard, Malvika Bhatnagar, Lisa McNeill, Mhairi Donnelly, Katie Frew, Avinash Aujayeb
{"title":"Hepatic Hydrothorax: A Narrative Review.","authors":"Benjamin Pippard, Malvika Bhatnagar, Lisa McNeill, Mhairi Donnelly, Katie Frew, Avinash Aujayeb","doi":"10.1007/s41030-022-00195-8","DOIUrl":"https://doi.org/10.1007/s41030-022-00195-8","url":null,"abstract":"<p><p>Hepatic hydrothorax (HH) represents a distinct clinical entity within the broader classification of pleural effusion that is associated with significant morbidity and mortality. The median survival of patients with cirrhosis who develop HH is 8-12 months. The diagnosis is typically made in the context of advanced liver disease and ascites, in the absence of underlying cardio-pulmonary pathology. A multi-disciplinary approach to management, involving respiratory physicians, hepatologists, and palliative care specialists is crucial to ensuring optimal patient-centered care. However, the majority of accepted therapeutic options are based on expert opinion rather than large, adequately powered randomized controlled trials. In this narrative review, we discuss the epidemiology, pathophysiology, clinical characteristics, and management of HH, highlighting the use of salt restriction and diuretic therapy, porto-systemic shunts, and liver transplantation. We include specific sections focusing on the role of pleural interventions and palliative care, respectively.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f1/5b/41030_2022_Article_195.PMC9458779.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10390825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pulmonary TherapyPub Date : 2022-09-01Epub Date: 2022-08-04DOI: 10.1007/s41030-022-00198-5
Roy A Pleasants, Armando D Bedoya, Joel M Boggan, Karen Welty-Wolf, Robert M Tighe
{"title":"The Eyes Have It-for Idiopathic Pulmonary Fibrosis: a Preliminary Observation.","authors":"Roy A Pleasants, Armando D Bedoya, Joel M Boggan, Karen Welty-Wolf, Robert M Tighe","doi":"10.1007/s41030-022-00198-5","DOIUrl":"https://doi.org/10.1007/s41030-022-00198-5","url":null,"abstract":"<p><strong>Introduction: </strong>The disease origins of idiopathic pulmonary fibrosis (IPF), which occurs at higher rates in certain races/ethnicities, are not understood. The highest rates occur in white persons of European descent, particularly those with light skin, who are also susceptible to lysosomal organelle dysfunction of the skin leading to fibroproliferative disease . We had observed clinically that the vast majority of patients with IPF had light-colored eyes, suggesting a phenotypic characteristic.</p><p><strong>Methods: </strong>We pursued this observation through a research database from the USA Veterans Administration, a population that has a high occurrence of IPF due to predominance of elderly male smokers. Using this medical records database, which included facial photos, we compared the frequency of light (blue, green, hazel) and dark (light brown, brown) eyes among white patients diagnosed with IPF compared with a control group of lung granuloma only (no other radiologic evidence of interstitial lung disease).</p><p><strong>Results: </strong>Light eye color was significantly more prevalent in patients with IPF than in the control group with lung granuloma [114/147 (77.6%) versus 129/263 (49.0%], p < 0.001), indicating that light-colored eyes are a phenotype associated with IPF .</p><p><strong>Conclusion: </strong>We provide evidence that light eye color is predominant among white persons with IPF.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/54/f3/41030_2022_Article_198.PMC9458811.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40601956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pulmonary TherapyPub Date : 2022-09-01Epub Date: 2022-08-15DOI: 10.1007/s41030-022-00193-w
Jaclyn A Smith, Michael M Kitt, Alan Bell, Nicolas Noulin, Anjela Tzontcheva, Megan McGratty Seng, Susan Lu
{"title":"Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial.","authors":"Jaclyn A Smith, Michael M Kitt, Alan Bell, Nicolas Noulin, Anjela Tzontcheva, Megan McGratty Seng, Susan Lu","doi":"10.1007/s41030-022-00193-w","DOIUrl":"https://doi.org/10.1007/s41030-022-00193-w","url":null,"abstract":"<p><strong>Introduction: </strong>Available therapies for acute cough, a condition frequently caused by a viral upper respiratory tract infection (URTI), have shown limited evidence of efficacy. Gefapixant, a P2X3-receptor antagonist, has demonstrated efficacy and safety in studies of the treatment of refractory or unexplained chronic cough, but its efficacy for treating acute cough has not been previously studied.</p><p><strong>Methods: </strong>This was a phase 2a, randomized, double-blind, placebo-controlled, parallel-group, pilot study. Healthy volunteers were randomized 1:1 to receive twice-daily gefapixant 45 mg or placebo and inoculated with human rhinovirus 16 to induce URTI and cough. Participants were observed while quarantined for 7 days after the start of treatment. The primary endpoint was awake cough frequency on day 3, which was objectively measured with a cough-recording device. Secondary endpoints included change from baseline to day 3 in subjective cough severity measures (cough severity visual analog scale, Cough Severity Diary) and cough-specific quality of life (Leicester Cough Questionnaire-acute).</p><p><strong>Results: </strong>Of the 46 participants who met inclusion criteria [mean (standard deviation, SD) age, 24.6 (6.5) years; females, n = 8], 40 completed the study (gefapixant, n = 21; placebo, n = 19). There was no significant difference in awake cough frequency on day 3 between the gefapixant and placebo groups [least squares means, 2.4 versus 2.7 coughs per hour, respectively; mean difference (95% confidence interval, CI), -0.3 (-2.3, 1.7); P = 0.75]. There were no significant between-group differences for any of the secondary endpoints. Peak cough frequency was low and occurred later in the study than expected (days 4-5). The safety profile was consistent with that of previous studies of gefapixant.</p><p><strong>Conclusion: </strong>Compared with placebo, gefapixant did not reduce the frequency or severity of acute cough secondary to induced URTI. Induced viral URTI produced mild symptoms, including lower cough frequency than observed in previous studies of patients selected for acute cough associated with naturally occurring URTI.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT03569033; EudraCT, 2017-000472-28; protocol number, MK-7264-013.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2c/bb/41030_2022_Article_193.PMC9458823.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40711271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}