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Background and aimsAllergic asthma has a considerable burden on the quality of life. A significant portion of moderate-to-severe allergic asthma patients need omalizumab, an anti-immunoglobulin-E monoclonal antibody, as an add-on therapy. In this phase III clinical trial P043 (Zerafil®, CinnaGen, Iran) efficacy, safety, and immunogenicity were compared with Xolair® (the originator omalizumab). The primary outcome was the rate of protocol-defined asthma exacerbations.MethodsExacerbation rates, Asthma Control Test (ACT) results, spirometry measurements, immunogenicity, and safety were evaluated. Each subject received either medication with a dose ranging from 150 to 375 mg based on pre-treatment serum total IgE level (IU/mL) and body weight (kg) every two or four weeks for a duration of 28 weeks.ResultsExacerbation rates were 0.150 (CI: 0.079-0.220) in the P043 group, and 0.190 (CI: 0.110-0.270) in the omalizumab group (per-protocol). The least squares mean differences of predicted Forced Expiratory Volume in the First second (FEV1) were -2.51% (CI: -7.17-2.15, P=0.29) and -3.87% (CI: -8.79-1.04, P=0.12), pre- and post-bronchodilator use. The mean ± SD of ACT scores at the screening and the last visit were 10.62 ± 2.93 and 20.93 ± 4.26 in P043 and 11.09 ± 2.75 and 20.46 ± 5.11 in the omalizumab group. A total of 288 adverse events were reported for the 256 enrolled participants. Among all, “dyspnea” and “headache” were the most reported ones. The overall incidence of adverse events (P=0.62) and serious adverse events (P=0.07) had no significant differences between the two groups. None of the samples were positive for anti-drug antibodies.ConclusionP043 was equivalent to omalizumab in the management of asthma in reduction of exacerbations. There was no significant difference in other efficacy and safety parameters.Clinical trial registrationwww.clinicaltrials.gov (NCT05813470) and www.IRCT.ir (IRCT20150303021315N20).

Background: Epidemic thunderstorm asthma is an observed increase in cases of acute bronchospasm following thunderstorms. This study aimed to compare the frequency of obstructive airway disease or bronchial hyperresponsiveness in subjects with thunderstorm-associated respiratory symptoms with subjects with similar symptoms presented at other times.Methods: A cross-sectional study from June to November of 2013 was conducted on subjects with thunderstorm-associated respiratory symptoms living in Ahvaz City, Iran. Thunderstorm-associated subjects were presented with asthmatic symptoms in thunderstorms, and other patients presented with similar symptoms at other times. Baseline spirometry was performed on patients to examine the presence of obstructive airway disease. In all patients with normal spirometry, a provocation test was applied. A comparison of qualitative and quantitative variables was made using the Chi-square and independent t test, respectively. All analyses were carried out using SPSS Statistics Version 22. A P value less than 0.05 was considered statistically significant. Results: Out of 584 subjects, 300 and 284 participants were in thunderstorm-associated and non-thunderstorm-associated groups, respectively. After the final analysis, 87 (30.6%) and 89 (33.3%) of the thunderstorm-associated subjects and non-thunderstorm-associated group, respectively, had pieces of evidence of airflow limitation (P=0.27). Among the patients with normal spirometry, 161 (81.72%) of the thunderstorm-associated patients and 100 (56.17%) patients of the non-thunderstorm-associated symptoms group had a positive methacholine challenge test result (P

Background: The coronavirus disease 2019 (COVID-19) has become the leading source of pneumonia outbreaks in the world. The present study aimed to compare the condition of intensive care unit (ICU) and non-ICU COVID-19 patients in terms of epidemiological and clinical features, laboratory findings, and outcomes in three cities across Iran.Methods: In a cross-sectional study, 195 COVID-19 patients admitted to five hospitals across Iran during March-April 2020 were recruited. Collected information included demographic data, laboratory findings, symptoms, medical history, and outcomes. Data were analyzed using SPSS software with t test or Mann-Whitney U test (continuous data) and Chi square test or Fisher’s exact test (categorical variables). P40 years, body mass index

IntroductionDue to insufficient data on patient experience with healthcare system among patients with chronic obstructive pulmonary disease (COPD), particularly in developing countries, this study attempted to investigate the journey of patients with COPD in the healthcare system using nationally representative data in Iran.MethodsThis nationally representative demonstration study was conducted from 2016 to 2018 using a novel machine-learning based sampling method based on different districts’ healthcare structures and outcome data. Pulmonologists confirmed eligible participants and nurses recruited and followed them up for 3 months/in 4 visits. Utilization of various healthcare services, direct and indirect costs (including non-health, absenteeism, loss of productivity, and time waste), and quality of healthcare services (using quality indicators) were assessed.ResultsThis study constituted of a final sample of 235 patients with COPD, among whom 154 (65.5%) were male. Pharmacy and outpatient services were mostly utilized healthcare services, however, participants utilized outpatient services less than four times a year. The annual average direct cost of a patient with COPD was 1,605.5 USDs. Some 855, 359, 2,680, and 933 USDs were imposed annually on patients with COPD due to non-medical costs, absenteeism, loss of productivity, and time waste, respectively. Based on the quality indicators assessed during the study, the focus of healthcare providers has been the management of the acute phases of COPD as the blood oxygen levels of more than 80% of participants were documented by pulse oximetry devices. However, chronic phase management was mainly missed as less than a third of participants were referred to smoking and tobacco quit centers and got vaccinated. In addition, less than 10% of participants were considered for rehabilitation services, and only 2% completed four-session rehabilitation services.ConclusionCOPD services have focused on inpatient care, where patients experience exacerbation of the condition. Upon discharge, patients do not receive appropriate follow-up services targeting on preventive care for optimal controlling of pulmonary function and preventing exacerbation.

Abstract Background Asthma and allergic complications are the most common chronic disorders in children and adolescents. This study aimed to determine the prevalence and severity of asthma, allergic rhinitis, eczema among schoolchildren, and some related risk factors. Methods The cross-sectional study was performed in 2019 and involved 4000 students aged 6–7 years and 4000 students aged 13–14 years (both girls and boys) from urban schools in Khuzestan Province, southwestern Iran. We used the multi-stage sampling method. Data were collected using the Persian version of the International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire. Results The prevalence of current wheeze, wheeze ever and asthma ever in the age group of 6–7 years was 3.8, 4.5, and 1.8%, respectively; in the age group of 13–14 years, it was 4.4, 5.9, and 3.4, respectively. In terms of gender, males (4.9, 6.0, and 2.7 percent, respectively) had substantially higher rates of current wheeze, wheeze ever, and asthma ever compared to the girls (2.8, 3.6, and 2.0 percent, respectively) (p

Background: Asthma essentially represents a chronic inflammatory disease that manifests as a lifelong condition with different severity throughout the life of patients with asthma. Pomegranate holds three times the antioxidant activity compared to other polyphenol-rich food sources like green tea, which may positively impact asthma.Aim of the study: This research aimed to investigate the pomegranate supplementation influences clinical symptoms, eosinophil, basophil, and neutrophil counts in patients with allergic asthma.Materials and Methods: Participants (n = 64) suffering from mild to moderate allergic asthma were randomly divided into two groups: The control group received placebo capsules and the intervention group received 250 mg pomegranate extract capsules twice a day (for 8 weeks). To analyze the data, we used SPSS software (version 22). The significance level of p-value was considered less than 0.05.Results: The findings showed that the pomegranate extract improved patients’ clinical symptoms like daily breath shortness, nocturnal breath shortness, and limitation of asthma-related activity in the intervention group compared to the control group. Furthermore, eosinophil, basophil, and neutrophil counts were significantly decreased in the intervention group. Also, by comparing the two groups, the levels of change in neutrophils and eosinophils were statistically significant.Conclusion: It appears that the pomegranate extract can ameliorate some clinical symptoms and reduce neutrophils, basophils, and eosinophils in allergic asthma patients.Clinical Trial Registration:https://www.irct.ir/trial/45612; identifier: IRCT20200205046384N1.

Background: There is no definitive treatment for COVID-19. Hemoperfusion and plasmapheresis have only been studied in a few cases of COVID-19. In this study, plasmapheresis-hemoperfusion and current treatment for COVID-19 patients were compared for mortality. Methods: In this cross-sectional study, 103 patients with COVID-19 underwent hemoperfusion, plasmapheresis, and conventional medical treatment in educational hospitals in Ahvaz, Iran. A census method was used to include the patients in the study. The data from the hospital file were used to complete a checklist containing demographic information, clinical findings, and paraclinical findings for all patients. Results: There was not a statistically significant difference (P-value = 0.051) between the plasmapheresis group (78.8%), the hemoperfusion group (71.9%), and the current treatment group (52.6%) in mortality rates. Hemoperfusion had a median survival time of 18.9 days, plasmapheresis had a median survival time of 16.9 days, and current treatment had a median survival time of 13.5 days. In terms of patient survival time, there was no significant difference (P-value = 0.181). Multiple regression results showed that death rates in the hemoperfusion (P = 0.393) and plasmapheresis (P = 0.073) groups were not statistically different from those in the current treatment group. Conclusion: As a result of this study, there were no differences between the treatment groups in regard to death rates or patient survival times.

Existing asthma treatments are associated with side effects and limitations, which has led to an interest in alternative and complementary therapies. Given the anti-inflammatory properties of pomegranate, the present study aimed to determine the impact of pomegranate extract supplementation on lung function parameters evaluated through spirometry, high-sensitivity C-reactive protein (hs-CRP), pro-oxidant antioxidant balance, and interleukin 35) (IL-35) in participants with mild and moderate allergic asthma (based on forced expiratory volume in 1 second (FEV1) and clinical symptoms). Participants with mild and moderate allergic asthma (n = 64) were randomly assigned to two groups: the intervention group, which received two pomegranate extract capsules (500 mg/day), or the control group for eight weeks. Also, the physician prescribed similar drugs to the participants in the study. Independent samples T-test and Mann–Whitney U were used to compare the quantitative outcomes between the intervention group and the comparison group. The Wilcoxon test and the paired T-test were applied for within-group comparisons. A p-value

Abstract Background From the beginning of the COVID-19 pandemic, the development of infrastructures to record, collect and report COVID-19‏ ‏data has become a fundamental necessity in the world. The disease registry system can help build an infrastructure to collect data systematically. The study aimed to design a minimum data set for the COVID-19 registry system. Methods A qualitative study to design an MDS for the COVID-19 registry system was performed in five phases at Ahvaz University of Medical Sciences in Khuzestan Province in southwestern Iran, 2020–2021. In the first phase, assessing the information requirements was performed for the COVID-19 registry system. Data elements were identified in the second phase. In the third phase, the MDS was selected, and in the four phases, the COVID-19 registry system was implemented as a pilot study to test the MDS. Finally, based on the experiences gained from the COVID-19 registry system implementation, the MDS were evaluated, and corrections were made. Results MDS of the COVID-19 registry system contains eight top groups including administrative (34 data elements), disease exposure (61 data elements), medical history and physical examination (138 data elements), findings of clinical diagnostic tests (101 data elements), disease progress and outcome of treatment (55 data elements), medical diagnosis and cause of death (12 data elements), follow-up (14 data elements), and COVID-19 vaccination (19 data elements) data, respectively. Conclusion Creating a standard and comprehensive MDS can help to design any national data dictionary for COVID-19 and improve the quality of COVID-19 data.

Objectives: In recent years, there has been a clear trend of increasing allergic diseases especially in children, and developing countries are no exception. Thepresentstudy sought to determine the risk factors associated with wheezing among school children aged 6–7 and 13–14 years living in Khuzestan Province, Iran. Study design: Cross-sectional. Methods: Data for this cross-sectional study is the history of wheeze in the last 12 months. The participants included 6-7- and 13-14-year-old girls and boys studying in urban schools in Khuzestan Province in 2019. We collected the data using the multi stage sampling technique as suggested in the International Study of Asthma and Allergies in Childhood (ISAAC). The research reviewed the literature and consulted experts to collect the risk factors for demographic and clinical information, environmental exposure and lifestyle. Results: Eight thousand questionnaires were handed out to both age groups, of which 7344 were completed. Two hundred ninety-nine (4.1 %) of the participants had current wheeze. Three-point four percent (124 individuals) in the 6–7 year age group and 4.8 % in the 13–14-year-old age group had current wheezing. The results of the logistic regression model suggest that the most significant risk factors associated with the chance of developing current wheeze in the both age groups are: being male (OR: 1.46, 95 % CI: 1.12–1.88), being from employed mother families (OR: 1.50, 95 %, CI:1.05–2.08), property ownership (OR:1.36, 95 %, CI:1.04–1.79) bugs in the property (OR: 1.29, 95 %, CI:0.99–1.70) mold in the property (OR: 1.75, 95 %, CI:1.12–2.76), pet(s) in the student's bedroom (OR: 1.75, 95 %, CI: 0.97–3.14), a family history of asthma and allergic diseases (OR: 2.20, 95 %, CI: 1.69–2.87), tobacco smoke exposures in the property (OR: 1.43, 95 %, CI:1.04–1.96), having allergic rhinitis (OR: 7.86, 95 % CI: 5.89–10.50) and eczema (OR: 3.85, 95 % CI: 2.10–7.08). Conclusions: Families are suggested to adopt strategies to reduce exposure to outdoor air pollutants and contain indoor allergens. More studies are necessary to further explore the effects of modifying and changing these risk factors.

Introduction: Diffusion of antibiotic resistance genes by horizontal gene transfer has led to the fast emergence of multidrug resistance (MDR) among bacteria. Multiple classes of integrons are effective genetic elements which play a significant role in the acquisition and nosocomial dissemination of resistance factors in strains of Gram-negative bacteria, Pseudomonas aeruginosa, and Acinetobacter baumannii. Methods: In this study, 110 sputum samples were collected from hospitalized patients with tract infections. Identification of the isolates was performed by standard biochemical tests. The most frequent Gram-negative isolates were 25 Enterobacteriaceae (62.5%), (9 Enterobacter spp, 11 Citrobacter spp, and 5 Escherichia coli), 6 P. aeruginosa (15%) and 9 Acinetobacter spp (22.5%). Susceptibility of the isolates to antibiotics was carried out by Kirby-Bauer disk diffusion method according to CLSI guidelines, and finally, the class 1 integrons were detected by PCR. Results: Maximum resistance rate among Gram-negative isolates was observed to ceftazidime, co-trimoxazole, and cefotaxime with 89%, 87%, and 82%, respectively. A low-level resistance was recognized for imipenem 32% and gentamicin 34%, while an intermediate level resistance was found against the norfloxacin 40% and ciprofloxacin 44%. Out of 6 P. aeruginosa and 9 A. baumannii isolates, 2 (33.3%) and 3 isolates (33.3%) were positive for class 1 Integrons, respectively, while all Enterobacteriaceae isolates (100%) were negative for class 1 Integrons. Class 1 integrons were detected among of MDR isolates. Conclusion: Our results showed that monitoring MDR isolates and detection of class 1 integrons in these isolates is necessary for promotion of antibacterial stewardship.

Background: Ventilator-associated pneumonia (VAP) is a common nosocomial infection among hospitalized patients who have undergone intubation and mechanical ventilation for more than 48 hours. Patients admitted to the intensive care unit (ICU) are at risk of developing life-threatening VAP due to specific conditions, especially with Gram-negative pathogens with advanced drug resistance. Hereby, the control of these agents and its monitoring is of particular importance. In this study, the pattern of antibiotic resistance of Gram-negative bacteria isolated from tracheal culture of patients with VAP investigated in ICU of Imam Khomeini Hospital of Ahwaz. Materials and Methods: In this cross-sectional study, tracheal samples were collected during April 2016 to April 2017 from patients who were on mechanical ventilation in ICU of Imam Khomeini Hospital in Ahwaz, Khuzestan province, southwest of Iran. After isolation, bacterial strains were identified using biochemical tests. Then, antimicrobial resistance pattern of these isolates investigated using standard disc diffusion according to clinical and laboratory standards institute 2016 (CLSI 2016) guidelines. Results: A total of 111 bacterial isolates were identified which were as following; Acinetobacter baumannii, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli, Stenotrophomonas maltophilia, and Serratia marcescens, with prevalence of 54%, 19.8%, 14.4%, 6.4%, 4.5%, and 0.9%, respectively. Antibiotic susceptibility test of isolates showed that almost all isolates had high resistance to treatment antibiotics and were multi-drug resistance (MDR). The A. baumannii isolates were resistant to ciprofloxacin and piperacillin-tazobactam, but ampicillin-tazobactam had a good effect. Conclusion: The results of this study showed that patients admitted to ICU due to their conditions of treatment are more likely to develop VAP by Gram-negative pathogens. The empirical treatment of VAP due to predominant bacterial causes and emerging drug resistance has become more challenging. It requires to use of multidrug regimens for routine clinical practice. It should be noted that in order to appropriate antimicrobial therapy, precise and correct diagnosis is very important.

Introduction: Phosphodiesterase inhibitors (PDEs) increase intracellular cyclic adenosine monophosphate, which results in a wide range of anti-inflammatory effects and pathologically leads to improve asthma disease. Because no human study has surveyed the effect of PDEs on pulmonary function, except some case reports and animal researches, we decided to perform a pilot study for evaluating the effect of sildenafil (PDE5) on pulmonary function in patients with severe asthma. Methods: This randomized controlled trials study was conducted on 20 patients with severe asthma in 2019 in Iran. For case group, was prescribed sildenafil (50 mg) daily and the control group received the placebo. In the beginning of the study and one month later, volume parameters, 6-minute walk distance (6MWD), and the quality-of-life questionnaire were measured and compared in the two groups. Results: Twenty patients were entered into this study. 8 patients (40%) were male and 12 (60%) were female. The results showed that mean forced vital capacity 1 in the sildenafil group turned from 1259 ± 170 to 1603 ± 527, while in the placebo group it changed from 1135 ± 125 to 1365 ± 251 (P-value = 0.215). There is no statistically significant difference between two groups. In addition, in comparison with placebo, sildenafil did not show any significant improvement in the volume parameters, the quality-of-life questionnaire scale, and 6MWD at the end of the study. Conclusion: According to present result can be concluded that sildenafil does not improve the severity of asthma and the quality of life in patients with severe asthma.

Vitamin D has several extra calcemic effects. Vitamin D deficiency is highly prevalent in chronic obstructive pulmonary disease (COPD) patients but little is known about it’s association with lung function. Objective: To investigate whether supplementation with vitamin D could improve pulmonary function in COPD patients. Design: Before and after, double center, clinical trial. Setting: Hazrat Rasoul University Hospital, Tehran, and Imam Khomaini University Hospital, Ahvaz, Iran. Participants: 24 patients with mild to very severe COPD. Intervention: Loading dose of 300,000–600,000 International Units (IU) of vitamin D, then 50000 IU weekly for 12 weeks. Measurements: The outcomes included forced expiratory volume in one second (FEV1), forced vital capacity (FVC), vital capacity (VC), forced expiratory flow between 25%–75% of forced vital capacity (FEF 25%–75%), exercise capacity according to the six minute walk test(6MWT) and the saturation of oxygen during exercise. Results: The mean FEV1 (p-value = 0.866), FVC (p-value = 0.475) and VC (p-value = 0.425) were not significantly different before and after intervention. FEF 25%–75% did not improve with this intervention (p-value = 0.555). The vitamin D supplementation did not have any significant effect on the exercise capacity (p-value=0.175) or the saturation of oxygen (p-value = 0.635). Conclusion: Pulmonary function and exercise capacity did not improve with vitamin D supplementation in COPD patients.

Background. This study compares different risk factors in patients visiting a hospital during five rainfall-associated bronchospasm epidemics in Ahvaz and those visiting on other occasions. Methods. This case-control study was conducted on 5307 patients with bronchospasm admitted to the Emergency Department of Imam Khomeini Hospital in Ahvaz (Iran) from late October to December (as the epidemic) and 916 patients admitted from late January to March (as the nonepidemic) in 2011 to 2015. Results. A total of the 41.7% of the cases and 48.8% of the controls had episodes of bronchospasm, suggesting a significant difference between the two groups (P

We undertook this randomized clinical trial to investigate whether adding furosemide to salbutamol could improve the peak expiratory flow rate (PEFR) and clinical signs of reactive airway disease (RAD) patients. Eligible 18- to 55-year-old patients were randomly divided into intervention and control groups. Patients received 5 mg of nebulized salbutamol and 40 mg of nebulized furosemide in the intervention group and 5 mg of nebulized salbutamol alone in the control group. Patients in both groups received 100 mg of methylprednisolone intravenously stat. Severity of the RAD was estimated before and 45 minutes after treatment in both groups. PEFR was estimated before treatment and at 15, 30, and 45 minutes later. Ninety patients were enrolled, 45 in each group. There were no significant differences between two groups regarding gender, mean age, and normalized PEFR. The baseline mean PEFR was not significantly different between groups (P=0.58). A repeated measure analysis of variance revealed that the differences between the two treatments was significant (P=0.0001) and the behavior of two treatments was not similar across the time (P=0.001). Comparison of clinical severity of acute RAD revealed no significant differences between groups at the end of the trial (0.06). This study showed that adding nebulized furosemide to salbutamol in RAD patients improved PEFR.