scholarly journals Inhaled budesonide versus oral prednisolone in the treatment of acute exacerbation of moderate bronchial asthma: an open label randomized clinical trial

2021 ◽  
Vol 9 (4) ◽  
pp. 1138
Author(s):  
Reashma Roshan ◽  
Mubashir H. Shah ◽  
Aejaz A. Bhat
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Acute Exacerbation ◽  
Bronchial Asthma ◽  
Inhaled Corticosteroids ◽  
Oral Prednisolone ◽  
Open Label ◽  
Oxygen Inhalation ◽  
Group B ◽  
Inhaled Budesonide

Background: Recently published studies have suggested that inhaled corticosteroids may offer benefit over systemic steroids in bronchial asthma. This research was carried out to study the efficacy of inhaled budesonide and to compare the efficacy of inhaled budesonide with oral prednisolone in the treatment of acute moderate asthma in children.Methods: This was an open label randomized clinical trial. Children in the age group of 1-12 years with acute exacerbation of asthma presenting to pediatric emergency from November 1, 2015 to October 31, 2016 who fail to show prompt improvement after initial treatment with oxygenand three doses of inhaled salbutamol, were enrolled. Children in group B (n=35) and group P (n=35) received inhaled budesonide and oral prednisolone, respectively, in addition to oxygen inhalation and salbutamol as per the study protocol. Outcome was measured in terms of pulmonary score at the beginning, at 6 hours, and at 24 hours of starting the treatment. The analysis was undertaken according to intent to treat principle.Results: Baseline characteristics (sex, age, weight, height, body mass index) were comparable in the 2 groups. Mean heart rate, respiratory rate, pulmonary score at 6 and 24 hours, mean SpO2 at 24 hours were significantly showing normalizing trend (p<0.05) and mean hospital stay was significantly reduced [2.60 (±0.60) vs 3.11 (±0.80); p<0.05] in group B as compared to group P.Conclusions: Outcome measures of clinical improvement were better in inhaled budesonide group than oral prednisolone group in acute moderate exacerbation of bronchial asthma. 

scholarly journals Lacrimal stenting versus three-snip punctoplasty for treatment of punctal stenosis or occlusion: An open-label, randomized clinical trial

2021 ◽  
Vol 10 (1) ◽  
pp. 24-31
Author(s):  
Haitham Rashdan ◽  
Ali Mahmoud Ismail ◽  
Mohammed Ezz-Eldawla ◽  
Mohammed Iqbal
Keyword(s):  
Clinical Trial ◽  
Patient Satisfaction ◽  
Randomized Clinical Trial ◽  
Open Label ◽  
Punctal Plugs ◽  
Silicon Tube ◽  
Group A ◽  
Group B ◽  
Punctal Stenosis

Background: To compare the short-term anatomical and functional outcomes of, as well as patient satisfaction with, lacrimal stenting and three-snip punctoplasty for the treatment of punctal stenosis or occlusion. Methods: In this open-label, randomized clinical trial, we included 50 eyes of 30 patients diagnosed with punctal stenosis or occlusion. They were randomly allocated to two groups of 25 eyes each, using central telephone randomization. Group A underwent a lacrimal stenting procedure and was subdivided into two subgroups: Group A1 (13 eyes) received polyvinylpyrrolidone-coated perforated punctal plugs, and Group A2 (12 eyes) received closed intubation using a bicanalicular silicon tube. Group B included 25 eyes that underwent three-snip punctoplasty. All eyes were examined after 1 day, 1 week, 1 month, 3 months, and 6 months. Postoperative anatomical success assessing the punctum size, functional success using the fluorescein disappearance test, and patient satisfaction based on epiphora scoring were recorded. Results: Both study groups were comparable in terms of sex and age distribution. Compared to Group B, Group A had a significantly larger punctum size at one, three, and 6-month postoperatively (P = 0.009, 0.01, and 0.02, respectively). The difference in FDT results was significant between the two groups at all follow-up visits (P = 0.008, 0.0001, 0.003, and 0.002, at postoperative one week, one-months, three-month, and six-month, respectively). Likewise, patient satisfaction was significantly different between both groups at all follow-up visits (P = 0.007, 0.001, 0.005, and 0.002, at postoperative one week, one-months, three-month, and six-month, respectively). Conclusions: Lacrimal stenting is an effective method for the treatment of punctal stenosis or occlusion. Overall, the FDT results and patient satisfaction outcomes were significantly better. Keywords: punctal occlusion, punctal stenosis, epiphora, lacrimal stenting, closed intubation, bicanalicular silicon tube, perforated punctal plugs, three-snip punctoplasty, 3-snip punctoplasty

scholarly journals The comparison of clinical efficacy of formoterol and fluticasone versus salmeterol and fluticasone in patients of bronchial asthma

2018 ◽  
Vol 7 (5) ◽  
pp. 947
Author(s):  
Akashdeep Rattu ◽  
Inderpal Kaur ◽  
Ashok Goel ◽  
Nirmal Chand Kajal
Keyword(s):  
Bronchial Asthma ◽  
Inhaled Corticosteroids ◽  
Beta Agonist ◽  
Fixed Dose ◽  
Dose Inhaler ◽  
Open Label ◽  
Group A ◽  
Baseline Values ◽  
Long Acting ◽  
Group B

Background: Fixed-dose combinations of Inhaled corticosteroids (ICS) and Long acting beta agonist (LABA) are established and widely used treatment for bronchial asthma when ICSs as monotherapy are ineffective. This study attempted to compare the efficacy of salmeterol and fluticasone with formoterol (newer LABA) and fluticasone in patients of bronchial asthma.Methods: An open label, randomized, prospective, parallel and comparative study of eight-week duration was conducted on 80 patients of bronchial asthma, with the collaboration of Department of pharmacology and Department of Tuberculosis and Chest Diseases Hospital, Government medical college, Amritsar. Patients in Group A were treated with 2 actuations of Formoterol and Fluticasone (6/125µg) twice daily and group B patients were treated with 2 actuations of Salmeterol and Fluticasone (50/125µg) twice daily for 8 weeks with metered dose inhaler (MDI). Patients in group A and B were assessed on day zero, 4 weeks and 8 weeks for clinical assessment and computerized spirometry for FVC, FEV1, FEV1/FVC and PEFR.Results: In group A mean±SD of FEV1 statistically significantly increased (<0.001) after eight week of therapy (1.50±0.12) from its baseline values (1.34±0.11). Similarly, in group B mean ± SD of FEV1 statistically significantly increased (<0.001) after eight weeks (1.48±0.13) from its baseline values (1.36±0.12). There was statistically significant (<0.001) improvement in other parameters of spirometry in patients of both the groups.Conclusions: It was observed that both the combination of Fluticasone + Formoterol and Fluticasone + Salmeterol are effective in the treatment of bronchial asthma.

scholarly journals To evaluate the efficacy of nebulized budesonide compared to oral prednisolone in the management of moderate exacerbation of acute asthma

2017 ◽  
Vol 4 (4) ◽  
pp. 1278
Author(s):  
Sushil Sharma ◽  
Rekha Harish ◽  
Neeti Dutt ◽  
Kishour Kumar Digra
Keyword(s):  
Inhaled Corticosteroids ◽  
Oral Prednisolone ◽  
Pediatric Emergency ◽  
Oxygen Inhalation ◽  
Budesonide Group ◽  
Nebulized Salbutamol ◽  
The Difference ◽  
Inhaled Budesonide ◽  
Effective Drugs ◽  
To Receive

Background: Corticosteroids are extremely effective drugs and are used extensively in the management of asthma. Inhaled corticosteroids may offer some benefit in patients with mild to moderate obstruction in acute exacerbation and also offer the advantage of administration directly to the lungs. Hence this study was done to evaluate the efficacy of nebulized budesonide as compared to oral prednisolone in the management of moderate exacerbation of acute asthma.Methods: A total of 80 children attending pediatric emergency of SMGS Hospital Jammu aged 1 to 18 years with a moderate exacerbation of asthma despite three salbutamol nebulizations were enrolled and randomized into two groups. First group recieved nebulized budesonide (800 mcg) at hourly intervals for three doses followed by twice a day (n=37) while second group recieved oral prednisolone 2 mg/kg/day in two divided doses (n=43). Both groups continued to receive oxygen inhalation and nebulized salbutamol (0.15 mg/kg/dose) initially at hourly intervals for 3 doses followed by 6 hourly. The pattern of response as observed by the pulmonary scores in the two groups was compared.Results: The pulmonary scores were significantly improved at 1, 2 and 6 hours after starting treatment in the budesonide group as compared to prednisolone group (p < 0.01) although the difference was not significant after 12 hours. Oxygen saturation also showed a significant early improvement.Conclusions: This early demonstrable significant improvement in the clinical parameters of the inhaled budesonide group apparently suggests that inhaled budesonide may be efficacious in treating moderate exacerbations of asthma. 

Melatonin reduces the mortality of severely-infected COVID-19 patients

2021 ◽  
Vol 4 (4) ◽  
pp. 613-616
Author(s):  
Dun-Xian Tan ◽  
Russel J Reiter
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Mortality Rate ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Mortality Reduction ◽  
Single Center ◽  
Open Label ◽  
Melatonin Treatment ◽  
The World

SARS-CoV-2 has ravaged the population of the world for two years. Scientists have not yet identified an effective therapy to reduce the mortality of severe COVID-19 patients. In a single-center, open-label, randomized clinical trial, it was observed that melatonin treatment lowered the mortality rate by 93% in severely-infected COVID-19 patients compared with the control group (see below). This is seemingly the first report to show such a huge mortality reduction in severe COVID-19 infected individuals with a simple treatment. If this observation is confirmed by more rigorous clinical trials, melatonin could become an important weapon to combat this pandemic.

scholarly journals Telemanagement of Home-Isolated COVID-19 Patients Using Oxygen Therapy With Noninvasive Positive Pressure Ventilation and Physical Therapy Techniques: Randomized Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Aya Sedky Adly ◽  
Mahmoud Sedky Adly ◽  
Afnan Sedky Adly
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Physical Therapy ◽  
Randomized Clinical Trial ◽  
Health Care System ◽  
Oxygen Therapy ◽  
Early Stage ◽  
Home Based ◽  
Group A ◽  
Group B

BACKGROUND With the growing stress on hospitals caused by the COVID-19 pandemic, the need for home-based solutions has become a necessity to support these overwhelmed hospitals. OBJECTIVE The goal of this study was to compare two nonpharmacological respiratory treatment methods for home-isolated COVID-19 patients using a newly developed telemanagement health care system. METHODS In this single-blinded randomized clinical trial, 60 patients with stage 1 pneumonia caused by SARS-CoV-2 infection were treated. Group A (n=30) received oxygen therapy with bilevel positive airway pressure (BiPAP) ventilation, and Group B (n=30) received osteopathic manipulative respiratory and physical therapy techniques. Arterial blood gases of PaO<sub>2</sub> and PaCO<sub>2</sub>, pH, vital signs (ie, temperature, respiratory rate, oxygen saturation, heart rate, and blood pressure), and chest computed tomography scans were used for follow-up and for assessment of the course and duration of recovery. RESULTS Analysis of the results showed a significant difference between the two groups (<i>P</i>&lt;.05), with Group A showing shorter recovery periods than Group B (mean 14.9, SD 1.7 days, and mean 23.9, SD 2.3 days, respectively). Significant differences were also observed between baseline and final readings in all of the outcome measures in both groups (<i>P</i>&lt;.05). Regarding posttreatment satisfaction with our proposed telemanagement health care system, positive responses were given by most of the patients in both groups. CONCLUSIONS It was found that home-based oxygen therapy with BiPAP can be a more effective prophylactic treatment approach than osteopathic manipulative respiratory and physical therapy techniques, as it can impede exacerbation of early-stage COVID-19 pneumonia. Telemanagement health care systems are promising methods to help in the pandemic-related shortage of hospital beds, as they showed reasonable effectiveness and reliability in the monitoring and management of patients with early-stage COVID-19 pneumonia. CLINICALTRIAL ClinicalTrials.gov NCT04368923; https://clinicaltrials.gov/ct2/show/NCT04368923

scholarly journals Effects of vitamin D supplementation on red cell indices and cytokines in patients with thalassemia: An open-label randomized clinical trial

2019 ◽  
pp. 170-179
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Randomized Clinical Trial ◽  
Thalassemia Major ◽  
Vitamin D Supplementation ◽  
Beta Thalassemia ◽  
Red Cell ◽  
Open Label ◽  
Hematological Indices ◽  
Red Cell Indices

Background and aim Deficiency of vitamin D is known as a health problem all over the world and a recognized clinical complication of beta thalassemia patients. Vitamin D acts as a hormone at the nuclear receptor rendering it a beneficial medication for a number of diseases. It is believed that vitamin D is important in the modulation of the inflammation system by regulating the formation of inflammatory cytokines and immune cells. This study aimed to investigate the effect of vitamin D supplementation on the red cell indices and cytokines levels in patients with beta thalassemia major, in an open label randomized clinical trial. Patients and Methods: this study performed an open-label randomized clinical trial in patients with beta thalassemia major. Forty-six patients completed the eight weeks clinical trial and were allocated to administer oral vitamin D3 supplement of 100,000 IU every two weeks as an add-on treatment. During the study, hematological indices, serum iron, ferritin, vitamin D, calcium and inflammatory markers (interleukin-6, interleukin-2 and interleukin-10) were evaluated before (at baseline) and after vitamin D supplementation for 8 weeks. Results: Vitamin D3 supplements significantly decreases interleukin-6 levels and elevates the serum levels of anti-inflammatory cytokines IL-2 and IL-10, it also significantly reduced serum ferritin level, but it did not alter the hematological indices. Conclusion: Our results suggest that administration of vitamin D has a potential anti-inflammatory role in beta thalassemia patients and reduces serum ferritin levels, which may reduce the burdens of iron overload in thalassemia patients.

Abstract 13345: Efficacy and Safety of an Anticoagulation Clinic in Low-income Brazilian Patients With Heart Disease: a Randomized Clinical Trial

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Maria A Martins ◽  
João A Oliveira ◽  
Daniel D Ribeiro ◽  
Cibele C César ◽  
Vandack A Nobre ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Disease ◽  
Randomized Clinical Trial ◽  
Incidence Rate ◽  
Latin American ◽  
Low Income ◽  
Efficacy And Safety ◽  
Low Literacy ◽  
Clinical Trial Registration ◽  
Group B

Introduction: Anticoagulation clinics (AC) have better impact on anticoagulation control than usual medical care (UMC). However, there is no randomized trial testing the results of AC in low-income realities. We sought to examine the performance of an AC in a group of patients treated at a Brazilian public hospital. Hypothesis: The assistance provided by AC presents difference in TTR when compared to the UMC. Methods: This was a randomized clinical trial to test the efficacy and safety of a recently-implemented AC over UMC in a group of outpatients with heart disease. The primary and secondary endpoints were time in the therapeutic range (TTR) and warfarin-associated complications, respectively. Overall, 280 patients were enrolled and randomly assigned to one of the two arms: group A: one year at AC (A1: first semester; A2: second semester); and group B: one semester receiving UMC (B1) and other at AC (B2). Results: The mean age was 56.8±13.1 years and patients were mostly female (54.6%). The median monthly income was 464 US dollars. Low literacy was predominant in this group of studied patients (>68%). A1 showed higher TTR (62.4±20.8%) than B1 (55.1±28.5%) (p=0.014). An improvement of TTR was observed within group B, rising from 55.1±28.5% (B1) to 62.2±23.1% (B2) (p=0.008). A1 showed lower incidence rate (IR) per patients-year (p-y) of total bleedings than B1 (incidence rate ratio (IRR): 0.78; p=0.041) and a decline in the IR p-y was found for intra-group comparisons, both presenting IRR 0.58; p<0.001. A1 showed lower IR p-y for thromboembolism than B1 (IRR=0.12; p=0.047). (Clinical trial registration: www.clinicaltrials.gov/. Identifier: NCT01006486) Conclusions: AC helped increase TTR and reduce warfarin-complications, even in low-income settings. Extending this assistance to similar populations in other Latin American countries could reduce hospitalizations and deaths related to warfarin use.

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