scholarly journals Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial

2021 ◽  
Author(s):  
Sanjay Ramakrishnan ◽  
Dan V. Nicolau ◽  
Beverly Langford ◽  
Mahdi Mahdi ◽  
Helen Jeffers ◽  
...  
Keyword(s):  
Health Care ◽  
Emergency Department ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Effective Treatment ◽  
Controlled Trial ◽  
Urgent Care ◽  
Open Label ◽  
Inhaled Budesonide ◽  
Randomised Controlled

AbstractBackgroundMultiple early hospital cohorts of coronavirus disease 2019 (COVID-19) showed that patients with chronic respiratory disease were significantly under-represented. We hypothesised that the widespread use of inhaled glucocorticoids was responsible for this finding and tested if inhaled glucorticoids would be an effective treatment for early COVID-19 illness.MethodsWe conducted a randomised, open label trial of inhaled budesonide, compared to usual care, in adults within 7 days of the onset of mild Covid-19 symptoms. The primary end point was COVID-19-related urgent care visit, emergency department assessment or hospitalisation. The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment.Results146 patients underwent randomisation. For the per protocol population (n=139), the primary outcome occurred in 10 participants and 1 participant in the usual care and budesonide arms respectively (difference in proportion 0.131, p=0.004). The number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was 8. Clinical recovery was 1 day shorter in the budesonide arm compared to the usual care arm (median of 7 days versus 8 days respectively, logrank test p=0.007). Proportion of days with a fever and proportion of participants with at least 1 day of fever was lower in the budesonide arm. Fewer participants randomised to budesonide had persistent symptoms at day 14 and day 28 compared to participants receiving usual care.ConclusionEarly administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery following early COVID-19 infection.(Funded by Oxford NIHR Biomedical Research Centre and AstraZeneca; ClinicalTrials.gov number, NCT04416399)Research in contextEvidence before this studyThe majority of interventions studied for the COVID-19 pandemic are focused on hospitalised patients. Widely available and broadly relevant interventions for mild COVID-19 are urgently needed.Added value of this studyIn this open label randomised controlled trial, inhaled budesonide, when given to adults with early COVID-19 illness, reduces the likelihood of requiring urgent care, emergency department consultation or hospitalisation. There was also a quicker resolution of fever, a known poor prognostic marker in COVID-19 and a faster self-reported and questionnaire reported symptom resolution. There were fewer participants with persistent COVID-19 symptoms at 14 and 28 days after budesonide therapy compared to usual care.Implications of all the available evidenceThe STOIC trial potentially provides the first easily accessible effective intervention in early COVID-19. By assessing health care resource utilisation, the study provides an exciting option to help with the worldwide pressure on health care systems due to the COVID-19 pandemic. Data from this study also suggests a potentially effective treatment to prevent the long term morbidity from persistent COVID-19 symptoms.

scholarly journals Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial

2021 ◽  
Author(s):  
Sanjay Ramakrishnan ◽  
Dan V Nicolau ◽  
Beverly Langford ◽  
Mahdi Mahdi ◽  
Helen Jeffers ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Phase 2 ◽  
Open Label ◽  
Inhaled Budesonide ◽  
Randomised Controlled

scholarly journals Feasibility & Efficacy of Deprescribing rounds in a Singapore rehabilitative hospital- a randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Andrew Peng Yong Wong ◽  
Tan Wan Ting ◽  
Ee Jia Ming Charissa ◽  
Tan Wee Boon ◽  
Kwan Yu Heng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Multidisciplinary Team ◽  
Controlled Trial ◽  
Total Daily Dose ◽  
Open Label ◽  
Rehabilitation Hospital ◽  
Link Type ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Deprescribing is effective and safe in reducing polypharmacy among the elderly. However, the impact of deprescribing rounds remain unclear in Asian settings. Hence, we conducted this study. Methods An open label randomised controlled trial was conducted on patients of 65 years and above, under rehabilitation or subacute care and with prespecified medications from a Singapore rehabilitation hospital. They were randomised using a computer generated sequence. The intervention consisted of weekly multidisciplinary team-led deprescribing rounds (using five steps of deprescribing) and usual care. The control had only usual care. The primary outcome is the percentage change in total daily dose (TDD) from baseline upon discharge, while the secondary outcomes are the total number of medicine, total daily cost and TDD up to day 28 postdischarge, overall side-effect rates, rounding time and the challenges. Efficacy outcomes were analysed using intention-to-treat while other outcomes were analysed as per protocol. Results 260 patients were randomised and 253 were analysed after excluding dropouts (female: 57.3%; median age: 76 years). Baseline characteristics were largely similar in both groups. The intervention arm (n = 126) experienced a greater reduction of TDD on discharge [Median (IQR): − 19.62% (− 34.38, 0.00%) versus 0.00% (− 12.00, 6.82%); p < 0.001], more constipation (OR: 3.75, 95% CI:1.75–8.06, p < 0.001) and laxative re-prescriptions (OR: 2.82, 95% CI:1.30–6.12, p = 0.009) though death and hospitalisation rates were similar. The median rounding time was 7.09 min per patient and challenges include the inconvenience in assembling the multidisciplinary team. Conclusion Deprescribing rounds can safely reduce TDD of medicine upon discharge compared to usual care in a Singaporean rehabilitation hospital. Trial registration This study is first registered at Clinicaltrials.gov (protocol number: NCT03713112) on 19/10/2018 and the protocol can be accessed on https://www.clinicaltrials.gov.

scholarly journals Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

2020 ◽  
Vol 6 (4) ◽  
pp. 00460-2020
Author(s):  
Michael G. Crooks ◽  
Jack Elkes ◽  
William Storrar ◽  
Kay Roy ◽  
Mal North ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Self Management ◽  
Open Label ◽  
Management Interventions ◽  
Randomised Controlled ◽  
The Impact

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.We explored the impact of myCOPD in patients with mild–moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, −1.27 (95% CI −4.47–1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09–1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46–5.85) in favour of myCOPD.The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

scholarly journals A physiotherapy-led transition to home intervention for older adults following emergency department discharge: protocol for a pilot feasibility randomised controlled trial

2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Mairéad Conneely ◽  
Aoife Leahy ◽  
Margaret O’Connor ◽  
Louise Barry ◽  
Gillian Corey ◽  
...  
Keyword(s):  
Older Adults ◽  
Emergency Department ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Adverse Outcomes ◽  
Medical Assessment ◽  
Index Visit ◽  
Randomised Controlled ◽  
Feasibility Rct

Abstract Background Older adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. The development of effective interventions to prevent such outcomes is a key priority for research and service provision. This paper reports a protocol designed to evaluate the feasibility of conducting a three arm randomised controlled trial (RCT) within the ED setting and in the patient’s home. The interventions are comprehensive geriatric assessment (CGA), ED PLUS and usual care. Methods The ED PLUS pilot trial is designed as a feasibility RCT conducted in the ED and Acute Medical Assessment Unit of a university teaching hospital in the mid-west region of Ireland. We aim to recruit 30 patients, aged 65 years and over presenting to the ED with undifferentiated medical complaints and discharged within 72 h of index visit. Patients will be randomised by a computer in a ratio of 1:1:1 to deliver usual care, CGA or ED PLUS during a 6-month study period. A randomised algorithm is used to perform randomization. CGA will include a medical assessment, medication review, nursing assessment, falls assessment, assessment of mobility and stairs, transfers, personal care, activities of daily living (ADLs), social supports and baseline cognition. ED PLUS, a physiotherapist led, multidisciplinary intervention, aims to bridge the transition of care between the index visit to the ED and the community by initiating a CGA intervention in the ED and implementing a 6-week follow-up self-management programme in the patient’s own home following discharge from the ED. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Discussion Rising ED visits and an ageing population with chronic health issues render ED interventions to reduce adverse outcomes in older adults a research priority. This feasibility RCT will generate data and experience to inform the conduct and delivery of a definite RCT. Trial registration The trial was registered in Clinical Trials Protocols and Results System as of 21st July 2021, with registration number NCT049836020.

scholarly journals Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting

BMJ ◽  
2021 ◽  
pp. e066952
Author(s):  
Annette Mollerup ◽  
Marius Henriksen ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Mette Kildevæld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Symptom Severity ◽  
Controlled Trial ◽  
Self Care ◽  
Community Dwelling ◽  
Care Group ◽  
Open Label ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Objective To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19. Design Non-drug, open label, randomised controlled trial. Setting Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021. Participants Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19. Intervention Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention. Main outcome measures Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days’ follow-up. Results 378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of −1.2 points (95% confidence interval −2.1 to −0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported. Conclusions In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores. Trial registration ClinicalTrials.gov NCT04530435 .

scholarly journals Oseltamivir for coronavirus illness: post-hoc exploratory analysis of an open-label, pragmatic, randomised controlled trial in European primary care from 2016 to 2018

2020 ◽  
Vol 70 (696) ◽  
pp. e444-e449 ◽  
Author(s):  
Samuel Coenen ◽  
Alike W van der Velden ◽  
Daniela Cianci ◽  
Herman Goossens ◽  
Emily Bongard ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Exploratory Analysis ◽  
Open Label ◽  
Novel Coronavirus ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

BackgroundPatients infected with the novel coronavirus (SARS-CoV-2) are being treated empirically with oseltamivir, but there is little evidence from randomised controlled trials to support the treatment of coronavirus infections with oseltamivir.AimTo determine whether adding oseltamivir to usual care reduces time to recovery in symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2).Design and settingExploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries.MethodPatients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2), were randomised to usual care or usual care plus oseltamivir. The primary outcome was time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache.ResultsCoronaviruses (CoV-229E, CoV-OC43, CoV-KU1 and CoV-NL63) were identified in 308 (9%) out of 3266 randomised participants in the trial; 153 of these were allocated to usual care and 155 to usual care plus oseltamivir; the primary outcome was ascertained in 136 and 147 participants, respectively. The median time to recovery was shorter in patients randomised to oseltamivir: 4 days (interquartile range [IQR] 3–6) versus 5 days (IQR 3–8; hazard ratio 1.31; 95% confidence interval = 1.03 to 1.66; P = 0.026).ConclusionPrimary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone. This may be of relevance to the primary care management of COVID-19.

scholarly journals Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial

BMJ ◽  
2009 ◽  
Vol 339 (oct20 1) ◽  
pp. b4074-b4074 ◽  
Author(s):  
R van Linschoten ◽  
M van Middelkoop ◽  
M Y Berger ◽  
E M Heintjes ◽  
J A N Verhaar ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Exercise Therapy ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Patellofemoral Pain Syndrome ◽  
Patellofemoral Pain ◽  
Open Label ◽  
Supervised Exercise ◽  
Randomised Controlled
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