The randomization procedure will be implemented by the Clinical Trial Unit of the University Hospital Basel, which will generate a randomization list with a 1:1 treatment allocation. Cough after an upper respiratory tract infection can be very bothersome and disabling in daily activities and has a significant impact on physical and psycho-social health, leading to impairment in quality of life (QoL) [2]. A treatment effect of 1.3 points increase will be considered as MCID. We would also like to recognize the support of Prof. Alastair Hay, MB ChB, MD, MRCP, DCH, MRCGP, DFFP, FHEA, Centre for Academic Primary Care, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Andreas Zeller. Follow-up calls lasting around 15min each are carried by research staff at the CTU, University Hospital Basel on days 7, 14 and 28 and at 3months after randomization. During the physical exam, your doctor will use a stethoscope to listen closely to your lungs as you breathe. To assess the robustness of our primary analysis, an analysis of the primary outcome without imputing data (complete case analysis) will be performed. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Study data entered in the eCRF are only accessible to authorized persons and an integrated audit trail will maintain a record of initial entries and any changes made, time and date of entry and user name of the person authorizing the entry or change. Am J Respir Crit Care Med. At baseline, the GP will hand participants the LCQ and will be available to answer questions. Those who agree to join the study will be asked to provide written consent and will be screened against the full eligibility criteria described above. Do you smoke or are you around tobacco smoke? It's a generic prescription medication that's used to treat a wide range of inflammatory and autoimmune health conditions in adults and children. Participants will complete the LCQ on paper at baseline and over the telephone at follow-up. BMJ. Naunyn Schmiedebergs Arch Pharmacol. Br J Gen Pract. Evaluation of a novel method to assess corticosteroid responsiveness in chronic obstructive pulmonary disease. 2012;2012:918368. J Environ Public Health. Two RCTs assessed inhaled corticosteroids for post-infectious cough [8, 9]. Ferri FF. Fast heartbeat, nervousness: Deltasone (prednisone) Corticosteroid: Oral: 20 mg tablet taken with food 1-4 times a day: Steroid drugs lower the activity of the immune system and decrease inflammation. Doc. It is typically self-limited, resolving within one to three weeks. An insurance covering the study activities is contracted through the Sponsors institution, the University of Basel. Someone who accompanies you may remember something that you missed or forgot. The causative pathogen for bronchitis is rarely identified (Table 25 ). Federal government websites often end in .gov or .mil. Travel-associated illness in older adults (>60 y). Thorax. In a study in general practice, no benefit from montelukast therapy was found in patients with post-infectious cough [24]. Verbal and written instructions on how the drugs should be taken will be provided to the study participants. health information, we will treat all of that information as protected health 2006;13(159):166. However, if your doctor suspects that you have a bacterial infection, he or she may prescribe an antibiotic. Our study aims to fill this gap by determining the benefits and harms of oral corticosteroids in the treatment of patients with post-infectious cough enrolled in an RCT carried in a primary care setting. For these conditions, there is strong evidence that short-term oral corticosteroids for 5days provide patient-relevant benefit without relevant harm [14]. Accessed 27 May 2020. van Buuren S, Groothuis-Oudshoorn K. Mice: multivariate imputation by chained equations in R. J Stat Softw. Seeking medical advice for cough is the most common reason for presentation to primary care practices worldwide [1], and in the USA alone between 2001 and 2002, there were around 600,000 general practitioner or outpatient setting visits made due to cough associated with a previous respiratory infection [44]. The authors concluded that no recommendation can be proposed due to the high heterogeneity and inconsistency of the studies and their results [11]. J Physiother. The presence or absence of colored (e.g., green) sputum does not reliably differentiate between bacterial and viral lower respiratory tract infections. (i have asthma). The ISF will be archived for 10years according to International Conference on Harmonisation Good Clinical Practice (ICH-GCP) [31]. 1 - 3 This may be appropriate for bronchitis associated with asthma or chronic obstructive pulmonary. Accessed Jan. 9, 2017. Madison MJ, Irwin RS. https://www.cdc.gov/getsmart/community/for-patients/common-illnesses/bronchitis.html. Placebo will be used as a comparator in this study to prevent various biases (in particular as the primary endpoint is patient-reported). 2010;43:113. N Engl J Med. Cookies policy. An update on measurement and monitoring of cough: what are the important study endpoints? Prednisone Doses: what is normal? Viruses are responsible for more than 90 percent of acute bronchitis infections. The CTU at the University Hospital Basel is tasked with handling the data management system and performing monitoring activities. Most of the studies included in the review had an unclear or high risk of bias [7]. To compute the t test, the current version of the R language and environment (R Foundation, www.r-project.org) function power.t.test of the stats package was applied. 2010;64(11):70111. Inhaled corticosteroid for persistent cough following upper respiratory tract infection. Ok being treated with prednisone for bronchitis, problem is after taking the 2 tabs this am as instructed my bp ( controlled with rx) is running 145-156/80-90 is this ok next 5 days or should i stop them not sure of what to do n can't see dr soon? The study is also supported by Prof. Dr. med. Data will be collected until the time of withdrawal and will be analysed in the intention to treat analysis. Common terminology criteria for adverse events. A meta-analysis examining the effects of antibiotics in patients with acute bronchitis showed reduction of cough at follow-up (number needed to treat = 5.6) but no change in patients' activity limitations. Participants will be asked to complete the standardized LCQ questionnaire and hand it to the GP on day 0. PubMed A previous systematic review and meta-analysis of randomized controlled trials (RCT) carried by our group provided a wide overview of treatment options for primary care patients with post-infectious cough and examined the patient-relevant benefits and potential harms of available therapies [7]. Chronic bronchitis is caused by exposure to tobacco smoke or other irritants. J Clin Med Res. The prednisone dosage depends on a lot of factors, but mostly on what you are using it for. A dose of 40 mg of prednisone will ensure sufficient pharmacokinetic activity to be able to reveal a potential treatment effect in post-infectious cough. 25th ed. Not applicable, no biological specimens are collected for the purposes of the OSPIC study. Inflammation. Missing data of all variables that are used in the statistical model to test the hypothesis will be imputed. Multiple imputation will be performed using the R package mice [36]. Educational text answers on HealthTap are not intended for individual diagnosis, treatment or prescription. Feel better! Although they are commonly used and suggested by physicians, expectorants and inhaler medications are not recommended for routine use in patients with bronchitis.22,23 Expectorants have been shown to be ineffective in the treatment of acute bronchitis.22 Results of a Cochrane review do not support the routine use of beta-agonist inhalers in patients with acute bronchitis; however, the subset of patients with wheezing during the illness responded to this therapy.23 Another Cochrane review suggests that there may be some benefit to high-dose, episodic inhaled corticosteroids, but no benefit occurred with low-dose, preventive therapy.24 There are no data to support the use of oral corticosteroids in patients with acute bronchitis and no asthma. Subgroup effects will be analysed by interaction tests and interpreted fully exploratory. 2016;62(1):53. include protected health information. Lancet. The health-related data will be stored in an anonymized way by using the participants code and can be analysed for the purposes of future research projects. Explore Mayo Clinic studies testing new treatments, interventions and tests as a means to prevent, detect, treat or manage this condition. Financial support: SNSF (Swiss National Science Foundation), Investigator Initiated Clinical Trials grant (IICT 2018 call, 33IC30_179657 3). Breztri Aerosphere is used as 2 inhalations, 2 times each day (2 puffs in the morning and 2 puffs in the evening) to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days). Post-infectious cough, also known as subacute cough, is defined as lasting between 3 and 8weeks following an upper respiratory tract infection [3]. Drug information provided by: Merative, Micromedex Along with its needed effects, a medicine may cause some unwanted effects. No RCT found clear patient-relevant benefits and most had an unclear or high risk of bias. A majority of the studies focused on patients with chronic cough and only two examined the benefits for post-infectious cough [11]. In order to respect the on-going pandemic situation, we added a question to the GPs baseline questionnaire asking whether a SARS-CoV-2 nasopharyngeal swab specimen had been obtained and asked the result of the test (positive/negative). French CT, Fletcher KE, Irwin RS. Good news: no longer have pneumonia, and I'm cleared that I don't have pancreatitis. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. However, at present, there is no established evidence-based treatment option for post-infectious cough, despite it being a very frequent condition. Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Bafadhel M, McKenna S, Terry S, Mistry V, Pancholi M, Venge P, Lomas DA, Barer MR, Johnston SL, Pavord ID, Brightling CE. 2020. https://doi.org/10.1016/j.rmed.2020.105939. After the end of the study, the lists will be sent to the Sponsor-Investigator and included in the Investigator Site File (ISF). CTCAE, Version 5.0. 2009;22(2):1558. McAllister WA, Winfield CR, Collins JV. Fluid retention is one of prednisone's most famous side effects. Accessed 19 Oct 2017. Ann Intern Med. The CTU will provide an electronic data capture solution (secuTrial database) for the storage of the participant CRFs. 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