Change In Forced Expiratory Volume Research Articles

Overall Response to Anti-IL-5/Anti-IL5-Rα Treatment in Severe Asthma Does Not Depend on Initial Bronchodilator Responsiveness

Positive bronchodilator responsiveness (BDR) (change in forced expiratory volume in 1 second [ΔFEV1] ≥+200 mL and ≥+12%) after inhalation of a short-acting beta-2 agonist has been an inclusion criterion in licensing trials of anti-interleukin 5/anti-interleukin 5 receptor alpha (anti-IL-5/anti-IL-5Rα) biologics in severe asthma. However, in clinical practice, patients with severe uncontrolled asthma frequently show a negative BDR. To investigate whether the response to anti-IL5/anti-IL5Rα therapies differs between patients with positive and negative BDR at baseline. Retrospective multicenter analysis of treatment outcomes in patients with severe asthma receiving anti-IL-5/anti-IL-5Rα stratified for baseline BDR. Of 133 patients included, 37 had a positive and 96 had a negative BDR at baseline. Following anti-IL-5/anti-IL-5Rα treatment, FEV1 improved significantly in both groups compared with baseline (P < .0001), with no significant difference between patients with positive and negative BDR (ΔFEV1+493 mL vs+306 mL; P= .06). Forced vital capacity (FVC) increased (ΔFVC:+85 mL vs+650 mL; P<.01) andresidual volume (RV) decreased (ΔRV+113 mL vs -307 mL; P < .01) significantly in patients with negative BDR. Median annualized exacerbations (0 vs 0; P = .7), reduction of exacerbation rate (Δexacerbations 0 vs -2; P= .07), continuous oral corticosteroids (OCS) use (Δpatients on OCS -35% vs -39%; P= .99) and improvement of Asthma Control Test (ACT) score (ΔACT 6 vs 5; P= .7) were similar in both groups. Multivariate logistic regression analysis showed no significant correlations of positive versus negative BDR with response parameters. Both groups improved following treatment with similar responses concerning reduction of OCS therapy, exacerbations, and improvement of symptom control. Pulmonary function also improved in both groups during anti-IL-5/anti-IL-5Rα treatment, with differences in response patterns noted.

Reduction in Postprandial Peak Glucose With Increased Technosphere Insulin Dosage.

Technosphere Insulin (TI) is an ultra-rapid-acting inhaled insulin. This study assessed the mean peak two-hour postprandial glucose concentration with the initial TI dose (dose 1) calculated per the current label (United State Prescribing Information) compared with a ~2× higher dose (dose 2). Secondary objectives were to evaluate hypoglycemia within the two-hour postprandial period, evaluate change in forced expiratory volume in one second (FEV1) before and after the two-hour postprandial period, and monitor for other adverse events. Twenty patients with diabetes, on basal-bolus insulin therapy, received an initial dose 1 of TI followed by the higher dose 2, one to three days later. Subjects received an identical meal for both visits, and TI doses were administered immediately prior to the meal. The higher dose 2 provided significant reductions in mean postprandial glucose excursion (PPGE) in the two-hour postprandial period starting from 45 minutes (P = .008) to 120 minutes (P < .0001). Mean peak glucose was reduced from 228.6 to 179.3 mg/dL (P < .001) at two hours. Two hypoglycemic events (one level 1, one level 2) were observed in a single subject during the two-hour postprandial period with dose 2. There were no significant changes in FEV1 after either dose of TI. The higher dose 2 reduced PPGE versus the current label recommended dose 1 within the two-hour postprandial timeframe without any new safety concerns. When confirmed with a larger study, this higher TI dosing recommendation may help patients and clinicians minimize immediate postprandial hyperglycemia when titrating TI for prandial glucose control.

Adherence and quality of life assessment in patients with asthma treatment with budesonide/formoterol via the Elpenhaler device: the COMPLETE study

BackgroundAsthma is a chronic inflammatory disease of the airways that causes recurring episodes of wheezing, breathlessness, chest tightness and coughing. Inhaled drugs on a daily basis are the cornerstone of asthma treatment, therefore, patient adherence is very important.MethodsWe performed a multicenter, open, non-interventional, observational, prospective study of 716 adult patients diagnosed with asthma receiving FDC (Fixed-dose combination) budesonide/formoterol via the Elpenhaler device. We assessed the adherence to treatment at 3 and 6 months (based on the MMAS-8: 8-item Morisky Medication Adherence Scale), the quality of life and change in forced expiratory volume in 1 s (FEV1) from baseline to follow-up.ResultsApproximately 80% of the patients showed medium to high adherence throughout the study. The mean (SD) MMAS-8 score at 6 months was 6.85 (1.54) and we observed a statistically significant shift of patients from the low adherence group to the high adherence group at 6 months. Moreover, after 6 months of treatment with FDC budesonide/formoterol, we observed an increase in the patients’ quality of life that as expressed by a change 2.01 (95%CI 1.93–2.10) units in Mini AQLQ (p < 0.0001) that was more pronounced in the high adherence group. The same trend was also observed in terms of spirometry (mean FEV1 2.58 L (0.85) at the end of the study, increased by 220 mL from baseline) with a higher improvement in the medium and high adherence groups.ConclusionsTreatment with FDC of budesonide/formoterol via the Elpenhaler device was associated with improvement in asthma-related quality of life and lung function over 6 months that were more prominent in patients with higher adherence.Trial registration: 2017-HAL-EL-74 (ClinicalTrials.gov Identifier: NCT03300076).

Functional state of the diaphragm in patients with cervical spinal cord injury at the stages of respiratory support

Objective. To analyze the role of the functional state of the diaphragm in patients with cervical spinal cord injury at the stages of respiratory support and to substantiate additional criteria for their readiness to transfer to spontaneous breathing.Material and Methods. The state of the diaphragm was assessed by ultrasound in 24 patients with spinal cord injury. The excursion of the diaphragm during quiet breathing, the excursion and thickness of the diaphragm during forced breathing, and the change in forced expiratory volume from the moment of admission till the end of mechanical ventilation were analyzed.Results. On the first day, on the background of mechanical ventilation, there was a significant decrease in the excursion and thickness of the diaphragm during forced breathing (p = 0.002; p = 0.008) which persisted up to 3 days (p &lt; 0.001; p &lt; 0.001); by the fifth day of mechanical ventilation, the indicators increased to the initial levels (p = 0.112; p = 0.433); and by the 10th day they exceeded the initial values (p &lt; 0.001). When comparing the excursion and thickness of the diaphragm during the transfer of patients to spontaneous breathing with the data on their admission, a significant difference was obtained (p &lt; 0.001; p &lt; 0.001). The dynamics of forced expiratory volume indicators was similar to those of diaphragm excursion during forced breathing.Conclusion. A peculiarity of the functional state of the diaphragm in patients with cervical spinal cord injury in the acute period was a significant decrease in diaphragm excursion and the development of ventilator-induced diaphragm dysfunction (VIDD) associated with mechanical ventilation in replacement modes. The tactics of early tracheostomy and the use of auxiliary ventilation modes determined the absence of progression of VIDD during prolonged mechanical ventilation. The presence of a strong correlation between the diaphragm excursion during forced breathing and the forced expiratory volume allows concluding that these indicators can be additional objective criteria for the readiness of patients with cervical SC injury to transfer to spontaneous breathing, since they reflect not only the functional state of the diaphragm, but also the state of the lung tissue.

Chest computed tomography improvement in patients with cystic fibrosis treated with elexacaftor-tezacaftor-ivacaftor: Early report

Rationale and ObjectivesCystic fibrosis transmembrane conductance regulator (CFTR) modulators have revolutionised the treatment of cystic fibrosis (CF). Chest computed tomography (CT) is key in the diagnosis and follow-up of anatomical damage to the lungs. Our study aimed to evaluate changes on lung CT scans of patients with CF after receiving elexacaftor-tezacaftor-ivacaftor (ETI) therapy for one year. Materials and MethodsWe conducted a retrospective, observational, single-centre study between 2018 and 2021 on adult patients with CF administered ETI. We reviewed chest CT scans before and at least one year after starting ETI. The Brody-II score (BSII) was measured by two experienced radiologists who were blinded to the treatment. Paranasal sinus CT scans and clinical and functional data were also compared. Wilcoxon tests were used to compare differences, and Spearman’s correlation coefficient was used to evaluate changes in forced expiratory volume in one second (FEV1) and total BSII. ResultsIn the period, 63 patients were given ETI, and 12 met the criteria for analysis. The inter-observer reproducibility of BSII was satisfactory (intraclass correlation coefficient = 0.83, 95% confidence interval 0.57–0.91). The BSII decreased after one year of treatment (−18 ± 16, p = 0.002) due to lower mucous plugging (−7 ± 4, p < 0.001) and peribronchial thickening (−9 ± 10, p = 0.002) scores. Bronchial, parenchymal, and hyperinflation scores were unchanged. Clinical and functional parameters were significantly improved, except for total lung capacity. The correlation between ΔFEV1 and Δtotal BSII was strong (r = 0.88, p < 0.001). The paranasal sinus CT score significantly improved with ETI treatment. ConclusionsETI decreased pulmonary and sinus morphological abnormalities after one year of treatment.

Isolation of Exophiala dermatitidis is not associated with worse clinical outcomes during acute pulmonary exacerbations in cystic fibrosis.

Introduction. The black yeast Exophiala dermatitidis has been isolated in respiratory samples from people with cystic fibrosis (CF). However, adequate detection may require longer incubation periods than the current UK national standard for CF respiratory samples. Furthermore, it is unclear whether isolation of E. dermatitidis is associated with poorer clinical outcomes in CF.Hypothesis/gap statement. E. dermatitidis does not cause clinically significant lung disease in CF adults.Aim. To evaluate differences in clinical outcomes over a 12 month period and during acute pulmonary exacerbations between CF adults with and without untreated E. dermatitidis.Methodology. Incubation times for respiratory samples on Sabouraud dextrose agar with chloramphenicol (SABC) plates at a large regional adult CF centre were extended from 2 to 7 days over a 1 month period. The number of patients from whom E. dermatitidis was isolated, and the length of incubation time prior to isolation, were recorded. Outcomes of treatment of exacerbations with intravenous antibiotics but in the absence of concomitant antifungal therapy were compared between those with and without E. dermatitidis, as were changes in lung function and body mass index (BMI) over a 12 month period.Results. Extended incubation unmasked the presence of E. dermatitidis in 22 of 132 patients; all isolations occurred after >48 h of incubation. Patients who isolated E. dermatitidis had lower rates of Pseudomonas aeruginosa isolation (P=0.02) and higher rates of non-tuberculous mycobacteria isolation (P=0.03), and were more likely to be prescribed a long-term antifungal medication (P=0.03), but had no differences in age, sex, baseline lung function or body mass index (BMI). There were no differences in response to treatment of acute exacerbations between patients with and without E. dermatitidis, or in change in forced expiratory volume in 1 s (FEV1), BMI and number of exacerbations over 12 months of follow-up.Conclusion. E. dermatitidis is not associated with worse clinical outcomes in CF. Given potential side effects and drug interactions, routine targeting of E. dermatitidis with antifungals during acute exacerbations is not advised.

A Pilot Randomized Trial of As-Needed Budesonide-Formoterol for Stepping Down Controller Treatment in Moderate Asthma with Complete Remission.

BackgroundThe use of low-dose inhaled corticosteroid-formoterol as reliever monotherapy has recently been recommended in the asthma treatment guidelines. However, the efficacy of this treatment strategy has not yet been determined during the stepping-down period in moderate asthma. This study aimed to evaluate the feasibility of reducing treatment to as-needed budesonide-formoterol (BFM) in moderate asthma with complete remission.MethodsWe randomly assigned 31 patients (8 males and 23 females with a mean age of 57.2 years) with complete remission of asthma by inhaled BFM (160/4.5 μg) twice daily to receive BFM (160/4.5 μg) as needed (16 patients), or budesonide (BUD) (200 μg) twice daily (15 patients). The study was an open-label study done for 48 weeks, with the primary outcome as the cumulative percentages of patients with treatment failure (asthma exacerbation or loss of asthma control or lack of satisfaction after using medications) in the two groups.ResultsSix patients (42%) using as-needed BFM had treatment failure, as compared with three patients (21.4%) using BUD maintenance (hazards ratio for as-needed BFM, 1.77; 95% confidential interval, 0.44–7.12; p=0.41). The changes in forced expiratory volume in 1 second were −211.3 mL with as-needed BFM versus −97.8 mL with BUD maintenance (difference, 113.5 mL; p=0.75) and the change in fractional exhaled nitric oxide was significantly higher in both groups, at 8.68 parts per billion (ppb) in the as-needed BFM group and 2.5 ppb. in the BUD maintenance group (difference, 6.18 ppb; p=0.049).ConclusionCompared with BUD maintenance, there were no significant differences in treatment failure rate in patients who received as-needed BFM during the stepping down period in moderate asthma. However, they showed reduced lung function and relapsed airway inflammation. The results are limited by imprecision, and further large RCTs are needed.

Efficacy and Safety of Single Inhaler Triple Therapy Versus Separate Triple Therapy in Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis

Purpose: This study aimed to compare the efficacy and safety of single inhaler triple therapy and separate triple therapy in the treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD).Methods: PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov databases were searched, and the search date was set from database inception until February 15, 2022. Randomized controlled trials of single inhaler triple therapy versus separate triple therapy, from which the results related to efficacy and safety profiles were extracted, and the methodologic quality and risk of bias were evaluated.Findings: Five published articles (6 clinical trials) were screened from 3437 articles with a total of 4075 patients receiving single inhaler triple therapy and 3533 patients receiving separate triple therapy. Compared with separate triple therapy, single inhaler triple therapy significantly increased the change in forced expiratory volume in 1 second from baseline (mean difference = 0.02 L; 95% CI, 0.00-0.05L; P < 0.01), and there was a statistical difference between the 2 groups. No significant difference was found between the single inhaler triple therapy and separate triple therapy groups in terms of moderate to severe exacerbation rate (relative risk [RR] = 0.97; 95% CI, 0.85-1.10; P = 0.63), the change in St. George's Respiratory Questionnaire from baseline (mean difference = 0.34; 95% CI, −0.88 to 1.57; P = 0.58), proportion of St. George's Respiratory Questionnaire responders (RR = 0.99; 95% CI, 0.92-1.06; P = 0.77), adverse events (RR= 1.07; 95% CI, 0.90-1.27; P = 0.42), serious adverse events (RR = 1.02; 95% CI, 0.88-1.18; P = 0.81), mortality (RR = 1.10; 95% CI, 0.65-1.86; P = 0.72), risk of pneumonia (RR = 0.86; 95% CI, 0.62-1.18; P = 0.34), and risk of cardiovascular events (RR = 1.22; 95% CI, 0.91-1.65; P = 0.18).Implications: Compared with separate triple therapy, single inhaler triple therapy appears to improve lung function in patients with moderate to severe COPD, especially in terms of forced expiratory volume in 1 second advantages. Single inhaler triple therapy may be a feasible and simplified option for patients with moderate to severe COPD; however, this conclusion needs to be further confirmed by future randomized controlled trials. (Clin Ther. 2022;XX:XXX–XXX) © 2022 Elsevier HS Journals, Inc.

Nutrition as a modifiable factor in the onset and progression of pulmonary function impairment in COPD: a systematic review.

ContextChronic obstructive lung disease (COPD) is a progressive lung disease characterized by persistent airflow limitation. An increasing amount of evidence suggests an effect of dietary quality on the risk of COPD in the general population and pulmonary function decline in patients with COPD.ObjectiveThe association of dietary intake and nutrient status with COPD risk and onset, as well as pulmonary function decline (change in forced expiratory volume in 1 second, forced vital capacity, or the ratio of the former to the latter) in patients with COPD was investigated in this systematic review.Data SourcesThe PubMed database was searched by combining terms of pulmonary function or COPD with diet, nutrient status, or nutritional supplementation.Data ExtractionOriginal studies and systematic reviews and meta-analyses were included. Articles obtained were independently screened for relevance on the bases of title and abstract by 2 researchers. Eventually, 89 articles were included in the analysis.ResultsThe unhealthy Western-style diet is associated with an increased risk of COPD and an accelerated decline of pulmonary function. Intake of fruit, vegetables, dietary fibers, vitamins C and E, polyphenols, and β-carotene were individually associated with lower COPD risk, whereas consumption of processed meat was associated with higher COPD risk. Data on the effect of dietary quality on pulmonary function decline in patients with COPD are limited and inconsistent. Strong evidence for beneficial effects on pulmonary function decline was found only for vitamin D supplementation.ConclusionConsidering the increasing burden of COPD, more attention should be given to dietary quality as a modifiable factor in disease development and progression in patients with COPD.Systematic Review RegistrationPROSPERO registration no. CRD42021240183.

Annual FEV1 Loss in Patients with Noncystic Fibrosis Bronchiectasis and Affecting Factors.

Bronchiectasis is a chronic respiratory disease characterized by sputum production, cough, and several bronchial infections. Lung function is an important parameter to evaluate and study in patients with bronchiectasis. This study aimed to evaluate the annual changes in forced expiratory volume in one second (FEV1) and related factors in patients with with noncystic fibrosis bronchiectasis. A total of 529 patients who were diagnosed as having bronchiectasis using computed tomography and followed at the bronchiectasis unit of the Cerrahpasa Medical Faculty at Istanbul University between 1996 and 2018 were included in this retrospective study. A total of 153 patients were included in the study. The mean age of the patients was 58.6 ± 16.8 years and 61% (n = 93) were female. The annual change of FEV1 and forced vital capacity was -39 ± 82 (minimum: -585, maximum: 355, median: -26) mL and - 44 ± 91 (minimum: -517, maximum: 303, median: -31) mL, respectively. There was no correlation in FEV1 decline between those with and without Pseudomonas colonization (P = 0.65). No correlation was found between the etiologic factors and the decline of FEV1. A correlation existed only between the first FEV1 and the decline of FEV1 (for the first FEV1%, P = 0.038 [R = -0.17]; for the first FEV1 [mL] P = 0.026 [R = -0.18]). An annual mean FEV1 loss of 39 mL was found in adult patients with noncystic fibrosis bronchiectasis. The annual mean FEV1 decline was found to be associated with the baseline FEV1 value. Physicians should exercise caution in this regard in patients with bronchiectasis with low FEV1 values.

Association between smoking cessation and alterations in forced expiratory volume in one second (FEV1). A Follow-Up Study from a Greek Tobacco Cessation Clinic.

Cigarette smoking is the most important preventable cause of several diseases such as malignancies, pulmonary and cardiovascular diseases. Smoking cessation is now supported by both behavioral counseling and medical pharmacotherapy and is the only effective approach for slowing down an accelerated decline in forced expiratory volume in one second (FEV1). Our study aims to examine changes in forced expiratory volume in one second (FEV1) after smoking cessation for smokers attending our smoking cessation clinic their correlation to smokers' demographic characteristics. 114 smokers (48 males and 66 females), with a mean age of 48.36±10.49 years, were enrolled. They were classified in 4 groups, according to their age; <40 years (Group Α), 41-50 years (Group Β), 51-60 years (Group C), >60 years (Group D) and underwent Spirometry on the 1st day of visit, one month (2nd visit) and, 3 months later (3rd visit). Statistically significant increase in FEV1 values at the 2nd and 3rd visit compared to the 1st visit was observed in smokers who quit smoking in Group Α, B and C (p<0.05). In addition, a statistically significant decrease in FEV1 values at the 2nd and 3rd visit compared to the 1st visit was noticed in smokers who continued smoking in Group B, C and D (p<0.05). Smoking cessation achieved through smoking cessation support led to the improvement of FEV1 values within 3 months. The greatest benefit was observed in smokers under the age of 60.

Association between beta-2 adrenergic receptor variants and clinical outcomes in children and adolescents with acute asthma.

ABSTRACTObjective To investigate whether different genotypes of p.Arg16Gly, p.Gln27Glu, p.Arg19Cys and p.Thr164Ile variants interfere in response to treatment in children and adolescents with moderate to severe acute asthma.Methods This sample comprised patients aged 2 to 17 years with a history of at least two wheezing episodes and current moderate to severe asthma exacerbation. All patients received multiple doses of albuterol and ipratropium bromide delivered via pressurized metered-dose inhaler with holding chamber and systemic corticosteroids. Hospital admission was defined as the primary outcome. Secondary outcomes were changes in forced expiratory volume in the first second after 1 hour of treatment, and for outpatients, length of stay in the emergency room. Variants were genotyped by sequencing.Results A total of 60 patients were evaluated. Hospital admission rates were significantly higher in carriers of the genotype AA relative to those with genotype AG or GG, within the p.Arg16Gly variant (p=0.03, test χ2, alpha=0.05). Secondary outcomes did not differ between genotypes.Conclusion Hospital admission rates were significantly higher among carriers of the genotype AA within the p.Arg16Gly variant. Trial registration: ClinicalTrials.gov: NCT01323010

Longitudinal changes in forced expiratory volume in 1\xa0s in patients with eosinophilic chronic obstructive pulmonary disease

BackgroundData on changes in lung function in eosinophilic chronic obstructive pulmonary disease (COPD) are limited. We investigated the longitudinal changes in forced expiratory volume in 1 s (FEV1) and effects of inhaled corticosteroid (ICS) in Korean COPD patients.MethodsStable COPD patients in the Korean COPD subgroup study (KOCOSS) cohort, aged 40 years or older, were included and classified as eosinophilic and non-eosinophilic COPD based on blood counts of eosinophils (greater or lesser than 300 cells/μL). FEV1 changes were analyzed over a 3-year follow-up period.ResultsOf 627 patients who underwent spirometry at least twice during the follow up, 150 and 477 patients were classified as eosinophilic and non-eosinophilic, respectively. ICS-containing inhalers were prescribed to 40% of the patients in each group. Exacerbations were more frequent in the eosinophilic group (adjusted odds ratio: 1.49; 95% confidence interval: 1.10–2.03). An accelerated FEV1 decline was observed in the non-eosinophilic group (adjusted annual rate of FEV1 change: − 12.2 mL/y and − 19.4 mL/y for eosinophilic and non-eosinophilic groups, respectively). In eosinophilic COPD, the adjusted rate of annual FEV1 decline was not significant regardless of ICS therapy, but the decline rate was greater in ICS users (− 19.2 mL/y and − 4.5 mL/y, with and without ICS therapy, respectively).ConclusionsThe annual rate of decline in FEV1 was favorable in eosinophilic COPD compared to non-eosinophilic COPD, and ICS therapy had no beneficial effects on changes in FEV1.

Inhaled Dry Powder Mannitol Treatment in Pediatric Patients with Cystic Fibrosis: Evaluation of Clinical Data in a Real-World Setting.

Background: Cystic fibrosis (CF) is a genetic disorder, in which defective clearance of airway secretions leads to progressive lung function loss. Inhaled mannitol is used to increase sputum and mucociliary clearance. There are little data from real-world studies on the effectiveness of mannitol in children. Our objective was to evaluate the spirometry and clinical results of mannitol in pediatric patients. Methods: We retrospectively reviewed the records of 30 children and adolescents with CF receiving inhaled mannitol who were already on recombinant human deoxyribonuclease (rhDNase) treatment. The change in forced expiratory volume in 1 second (FEV1) from baseline at 2-4 months was the primary outcome. Secondary measures were other spirometry results, body mass index (BMI), hospital admissions, sputum characteristics, and positive bacterial colonization. Results: Compared to baseline, we found significant improvement in percent predicted FEV1 at 2-4 months of treatment; 84.50 (58.00-99.00) vs. 96.00 (66.00-106.00) (P = 0.0007). The absolute change in FEV1 was +11.5% at 2-4 months, +6.5% at 5-7 months, and +4% at 8-12 months. Also, significant improvements in other spirometry results were observed. Adolescents had significantly lower FEV1 results, but the improvement in their lung function was sustained for a more extended period than children. Mannitol provided easier sputum removal, increased sputum volume, significant decline in hospitalizations, and significantly fewer patients with positive sputum cultures. A significant increase in BMI at 8-12 months was observed. Cough was the most frequent adverse effect. Conclusion: In a real-world setting, our results demonstrated that adding mannitol to rhDNase therapy is tolerable in pediatric patients with CF and may provide improved spirometry and clinical outcomes. In addition, our results showed that mannitol provided recovery in overall lung function at 2-4 months, which was sustained up to 12 months together with improved BMI, easier sputum removal, and a decline in bacterial colonization and hospital admissions. However, cough was the most frequent side effect.

Randomised controlled trial of nebulised gentamicin in children with bronchiectasis.

AimFollowing trials of inhaled antibiotics in adults, this study investigates the efficacy of nebulised gentamicin to improve respiratory function in children with bronchiectasis.MethodsThis is a randomised, double‐blind, placebo‐controlled, crossover trial of 12‐week nebulised placebo/gentamicin, 6‐week washout, 12‐week gentamicin/placebo. Participants were children (5–15 years) with bronchiectasis, chronic infection (any pathogen), and able to perform spirometry from a hospital bronchiectasis clinic. Primary outcomes were change in forced expiratory volume in 1 s (FEV1) and hospitalisation days. Secondary outcomes included sputum bacterial density, sputum inflammatory markers, additional antibiotics and symptom severity. Analyses were on an intention‐to‐treat basis.ResultsFifteen children (mean 11.7‐years‐old) completed the study. There was no significant change in mean FEV1 (56%/55%, P = 0.38) or annual rate of hospital admissions (1.1/0, P = 0.12) between gentamicin and placebo, respectively. However, Haemophilus influenzae sputum growth (27% vs. 80%, P = 0.002) and bacterial density (2.4 log10 cfu/mL lower P < 0.001) improved with gentamicin. Sputum inflammatory markers interleukin‐1β (P < 0.001), interleukin‐8 (P < 0.001) and tumour necrosis factor‐α (P = 0.003) were lower with gentamicin. Poor recruitment limited study power and treatment adherence was challenging for this cohort.ConclusionsIn this crossover study of nebulised gentamicin in children with bronchiectasis, there was a reduction in sputum bacterial density and inflammation. However, there were no major improvements in clinical outcomes and adherence was a challenge.

Assessment of the acute bronchodilator test and the efficacy of the course of treatment with Glycopyrronium bromide in patients with pulmonary tuberculosis associated with chronic obstructive pulmonary disease

Background. Despite significant progress in the fight against tuberculosis, the number of new cases in the world remains relatively stable, and amounts are more than 10 million annually. Chronic obstructive pulmonary disease (COPD) negatively affects the quality of life in patients with pulmonary tuberculosis and reduces the effectiveness of chemotherapy. Correction of bronchial obstruction in pulmonary tuberculosis remains an actual problem.&#x0D; Aim. To assess the acute bronchodilator test with glycopyrronium bromide, pulmonary function test parameters changing within 24 hours after inhalation, as well as the effect of a 23-month course of treatment with glycopyrronium bromide on the same parameters and the quality of life in patients with pulmonary tuberculosis associated with chronic obstructive pulmonary disease.&#x0D; Material and methods. A prospective cohort study of 38 patients with active pulmonary tuberculosis associated with the chronic obstructive pulmonary disease treated with anti-tuberculosis chemotherapy was carried out. The pulmonary function test parameters were assessed before inhalation, 15, 30, 120 min, 23 h 45 min after a single inhalation of glycopyrronium bromide, as well as after 1, 2 and 3 months of treatment. Quality of life was assessed by using CAT (COPD Assessment Test), SF-36 (Short Form-36 Health Survey Questionnaire), SGRQ (St. Georges Respiratory questionnaire).&#x0D; Results. A single inhalation of 50 g glycopyrronium bromide led to a significant increase in forced expiratory volume in 1 second by +15.2%, +18.3%, +22.8% and +11.2% after 15, 30, 120 minutes and 23 h 45 min, respectively. The change in forced expiratory volume in 1 second after 1, 2 and 3 months of treatment was +13.1%, +9.3% and +11.7%, respectively. The overall CAT score after 3 months decreased by 7. The mental health index SF-36 increased by 9.2 points. A decrease in SGRQ parameters was revealed: symptoms by 21.7 points, physical activity by 14.8 points, impact by 18.2 points.&#x0D; Conclusion. Inhaled glycopyrronium bromide 50 g once daily can be recommended for the treatment of patients with active pulmonary tuberculosis associated with chronic obstructive pulmonary disease.

Respiratory Effects of Treatment with a Glucagon-Like Peptide-1 Receptor Agonist in Patients Suffering from Obesity and Chronic Obstructive Pulmonary Disease.

PurposeChronic obstructive pulmonary disease (COPD) affects millions of people worldwide. Obesity is commonly seen concomitantly with COPD. People with COPD have reduced quality of life, reduced physical activity, chronic respiratory symptoms, and may suffer from frequent clinical exacerbations. Liraglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved for weight loss and treatment of type-2 diabetes mellitus. In addition, liraglutide exerts anti-inflammatory actions by reducing IL-6 and MCP-1 levels. We investigated the effect of liraglutide on pulmonary function in people suffering from obesity and COPD.Patients and MethodsIn this controlled, double-blind trial, 40 people with obesity and COPD from two outpatient clinics were allocated randomly to receive liraglutide (3.0 mg, s.c.) or placebo (s.c.) for 40 weeks. At baseline and after 4, 20, 40, and 44 weeks, participants underwent pulmonary-function tests, 6-min walking test, and replied to a questionnaire regarding the clinical impact of COPD (COPD assessment test (CAT)-score).ResultsCompared with placebo, liraglutide use resulted in significant weight loss, increased forced vital capacity (FVC) and carbon monoxide diffusion capacity, and improved CAT-score. We found no significant changes in forced expiratory volume in one second (FEV1), FEV1/FVC, or 6-min walking distance.ConclusionIn patients suffering from obesity and COPD, 40 weeks of treatment with liraglutide improved some measures of pulmonary function. Our study suggests that liraglutide at 3.0 mg may be appropriate treatment in patients with obesity and COPD.

The Effect of Deployment on Pulmonary Function in Military Personnel With Asthma.

Military personnel with a diagnosis of asthma report increased respiratory symptoms in the deployment and post-deployment periods. The long-term effect of deployment on pulmonary function in this population is unknown. This study sought to determine the effect of deployment on post-deployment pulmonary function in active duty military personnel with asthma. A retrospective chart review of active duty military personnel with deployment to southwest Asia and an ICD-9 diagnosis of asthma with documented pre- and post-deployment spirometry was performed. A total of 642 active duty individuals with a diagnosis of asthma and documented spirometry with deployment to southwest Asia between 2006 and 2015 were identified. Of these, 76 individuals were identified with pre- and post-deployment spirometry. There was no significant change in the post-deployment forced expiratory volume at 1 second (% predicted), from 86.0 ± 14.8 to 87.6 ± 14.4 (P = .30). There was no significant change in post-deployment forced vital capacity (% predicted), from 93.8 ± 12.4 to 94.9 ± 12.1 (P = .42). The absolute change in forced expiratory volume at 1 second (L) after bronchodilator administration was decreased from pre-deployment to post-deployment (+0.31 ± 0.26 to +0.16 ± 0.23; P = .02). There was no significant post-deployment change in spirometry in this military population with asthma deployed to southwest Asia. These findings suggest that deployment itself is not associated with any short-term deleterious effect on post-deployment spirometric measures of lung function in many military personnel with asthma.

Role of the lung function test in asthmatic children admitted to Al-Azhar University (Assiut)

Background and aim Lung function, especially spirometry, is an important investigatory tool in the evaluation of asthma in children. This study aimed to compare the clinical condition of asthmatic children using the lung function test before and after treatment and after 3 months as a follow-up of asthmatic patients admitted to Al-Azhar Assiut University Hospital. Patients and methods This clinical study was a prospective study that included 60 asthmatic children aged 6–16 years with bronchial asthma plus 30 children matched for age, sex and nutritional status as a control group over a period of 13 months from December 1, 2019 to December 31, 2020. Results The age of the children included in this study was found to be mean±SD 9.033±2.843, with a male predominance (male : female ratio 58% : 42%) and a positive family history of asthma (61%) and other allergic disorders (65%). There was a statistically significant change in forced expiratory volume at first second (FEV1), forced vital capacity (FVC), and the FEV1/FVC ratio that showed considerable improvement in both age groups at admission, after receiving the suitable treatment and at follow-up 3 months after discharge. Conclusion Pediatric asthma is a major clinical concern and represents a huge burden on the family and society, hence the importance of prompt and early diagnosis that includes lung function testing, especially FEV1, FVC, and FEV1/FVC ratio, in not only diagnosis but also for monitoring the efficacy of treatment and follow-up.

Effect of Dupilumab in Korean Patients With Uncontrolled Moderate-to-Severe Asthma: A LIBERTY ASTHMA QUEST Sub-analysis.

PurposeTo assess the effect of dupilumab on the annualized severe exacerbation rates, change in forced expiratory volume at first second (FEV1), overall asthma control and health-related quality of life in Korean patients from the LIBERTY ASTHMA QUEST study.MethodsOf the 1,902 patients enrolled in the LIBERTY ASTHMA QUEST study, a phase-3, randomized, double-blind, placebo-controlled, parallel-group study on dupilumab, 74 (4%) were Korean. The patients were randomly assigned to 4 treatment groups (2:2:1:1). The sub-analysis reported herewith was performed with the pooled groups of dupilumab and placebo from the 4 original treatment groups in the LIBERTY ASTHMA QUEST study. The efficacy endpoints were annualized rate of severe exacerbation events during the 52-week study period and changes from baseline in pre-bronchodilator FEV1 in week 12. Asthma control, asthma quality of life and the effect of treatment on the levels of type 2 inflammatory biomarkers were assessed. The safety profile was also evaluated.ResultsIn Korean patients, annualized severe exacerbation rates were reduced with dupilumab (n = 49) compared to placebo (n = 25) (0.259 vs 1.942) during the 52-week treatment period. The relative risk reduction with dupilumab was 87% (P < 0.001). Improvements in pre-bronchodilator FEV1 (mean difference of 0.24 L, P = 0.021) were observed in week 12 in dupilumab-treated patients. Additionally, improvements in asthma control and asthma-related quality of life were observed; the FeNO and serum immunoglobulin E levels were reduced. The incidence of adverse events and serious adverse events was comparable between the dupilumab and placebo group. A total of 11 patients from the dupilumab group reported 63 injection site reactions.ConclusionsDupilumab, as an add-on therapy in severe asthma, is efficacious and has an acceptable safety profile in Korean patients.Trial RegistrationClinicalTrials.gov Identifier: NCT02414854