One dr would NOT prescribe, told me it would kill me.. I have chronic cough. Would lije to kniw how bad for me I am 70 years old.. Dorthe, Unfortunately we cannot provide specific medical advice especially in a public forum , without a consultation. God Bless and be safe. Andre, unfortunately we cannot provide specific medical advice especially in a public forum , without a consultation.
CirrusMED physicians are able to address your concern. Ronald, unfortunately we cannot provide specific medical advice especially in a public forum , without a consultation. Check out our membership options. Inhaled corticosteroids such as Qvar, Pulmicort, Flovent and others are generally indicated for long term management of inflammatory lung conditions like asthma and COPD. Sometimes they are used to treat a chronic cough associated with these and other inflammatory lung conditions.
Acute, short term use of a steroid inhalers may or may not help a cough. According to me best option is eating honey with black pepper, really worked for me. Thanks for sharing. This is my 4th day of severe bronchitis. DR called in zpak. Now I have coughed so much, I am nauseated. Went back to hard green. I have gone thru 4 boxes of Kleenex. Also taking mucinex. I am getting worried. No better. CirrusMED physicians are able to address your concerns and prescribe medications if deemed necessary.
Is it ok to use Flovent with prednisone? One is local vs systemic. I was prescribed to the both. Prednisone should take care of any inflammation.. You need to take down your recommendation for steroids now that studies have shown conclusively that steroids do not help with strength or duration of symptoms with bronchitis. Also, all people commenting here should be aware that the majority of bronchitis cases are viral and CANNOT be helped with antibiotics. Doctors prescribe antibiotics, anyway, because patients demand the doctor do something.
JHS makes an excellent point. Steroids, antibiotics and albuterol should be used judiciously as the majority of bronchitis cases are self-resolving viral infections. When in doubt, seek advice from your physician especially if you have a history of chronic bronchitis, emphysema ,COPD, asthma or previous pneumonia. In the past 6 months I have been hit with acute asthmatic bronchitis.
The first time I was sick for 6 weeks and was miserable. Before this I was taking mucinex and delays daily and seeping with almost 3 pillows every night. This is after one day!! So instead of telling people to stay away, maybe you should let them make up their own minds bc this is absolutely helping me.
Do you mind if I ask what dose you are on? I rarely get sick. Went to a cheesy local emergency clinic. All this negative press about anti-biotics is hyper-vigilant cow waste. It seems every common cold now turns into bronchitis for me and my family. The rest of my family gets the flu shot and seems to get sick way more often then I do. I doubt it. You poor people.
My chronic Cough has lasted 12 years. I have seen at least 15 Drs, Eight procedures and to many meds to count. Nothing has worked. Why is it that doctors now do not want to prescribe anything with codeine in it? I know it can be addicting but when you have a bad cough from having bronchitis and no other non codeine medicine works, just prescribe one bottle of the medicine. In addition, studies have demonstrated possibly more harm than good when prescribing opiates for cough not necessarily addiction fear, but respiratory suppression.
Lastly, most controlled medications cannot be prescribed online, or via telemedicine. All that being said, establishing a trusted relationship with a primary care physician is your best bet when it comes to deciding whether a controlled medication is right for you. Your email address will not be published.
This site uses Akismet to reduce spam. Learn how your comment data is processed. Fax: support cirrusmed. Coughing Sucks! Danielle Radaelli on November 29, at pm. Will ibuprofen help decrease bronchial irritation of asthma. Cheryl williams on December 27, at pm. No it makes it worse Reply.
Brian on December 25, at pm. Richard Claus on July 8, at am. Robert W Evinger on January 31, at pm. Sounds like my condition. Please let me know if you discover a solution. Shannon on December 31, at pm. Mike smith on April 16, at pm. Ty- Mike Reply. Nina on January 3, at pm. Lloyd on July 7, at pm. Lloyd W Bone on July 7, at pm. Not 65 , 5 days Reply. Donna haynes on January 14, at am.
How do you know if yellow mucus is an infection or just bronchitis Reply. Lisa light on January 27, at am. Tom on February 28, at am. Will medrol pack decrease inflammation causing wheezing associated with acute bronchitis Reply. Candace on March 8, at pm. Dorthe Carmignani on March 30, at am. Joe on September 13, at pm. Admin most always has the same response. Not much help. Shannon on July 28, at pm. Andre Johnson on April 5, at pm. Ronald DelGiudice on June 16, at am.
Is there a prescription steroid inhaler that helps with coughs? Gordon on October 30, at pm. Thanks, The information provided was helpful …. Thanks for sharing Reply. Good to know! Peggy Langley on November 9, at pm. Nona on November 13, at pm. Research and anecdotal evidence suggests that European clinicians have started prescribing corticosteroids for LRTI in the absence of chronic obstructive pulmonary disease COPD [ 29 ], even though there is limited evidence to support their use for this condition.
Long-term steroid use is known to be associated with an array of unwanted systemic side effects such as adrenal suppression, impaired skin collagen synthesis and metabolic disturbances [ 30 , 31 ]. However, in the absence of specific contraindications [ 30 , 32 ], a short up to 1 week course of high-dose corticosteroids is considered to be safe and associated with few side effects [ 32 - 34 ].
The rationale for testing the effectiveness of corticosteroids in LRTI can be summarised as follows: i there is good evidence of oral steroid effectiveness for acute asthma; ii the symptoms of LRTI overlap with those of acute asthma; iii prednisolone tablets at a dose of 40 mg daily for 5 to 7 days is the most commonly used oral steroid for acute asthma; iv there is pharmacokinetic evidence to suggest that a minimum dose of 20 mg daily is required for non-asthmatic patients [ 35 ]; and v it is important that the first trial of its kind uses an adequate dose to detect any potential effects as a proof of concept.
This double-blind randomised controlled trial will provide high quality evidence to determine whether steroids are effective in the symptomatic treatment of acute LRTI, for which, to date, non-steroidal anti-inflammatory drugs [ 13 ], antibiotics [ 9 ] and inhaled corticosteroids [ 6 ] have been shown to be ineffective. A double-blinded, maximum dose design has been chosen since: i the primary outcomes are subjective in that cough severity is reported by the participant ; and ii treatment with this agent for this clinical problem is novel, making a trial demonstrating effectiveness under optimal conditions important.
In another study, participants reported symptoms between days 2 and 4 as being the worst problem [ 2 ], which provides the rationale for the timing for the second primary outcome in this trial. We recognise the undesirability of further medicalisation of common and self-limiting infections in primary care [ 36 ], and if this trial demonstrates a clinically important treatment effect, we do not think it will be appropriate to promote the routine use of high-dose corticosteroids for acute LRTI though we recognise that the prescription of corticosteroids to alleviate the most acute symptoms of chest infections remains a clinical decision.
Rather, we think the implication will be that further trials of lower-dose oral or inhaled corticosteroids should be conducted. If no treatment effect is found, it is unlikely that further, lower-dose steroid research would be warranted for acute LRTI. This study is a placebo-controlled, individually randomised, superiority trial in UK general practice.
We wish to test the effects of corticosteroids in adults presenting to primary care with acute LRTI, in whom there is no evidence of pneumonia or other reason to require an immediate antibiotic or hospitalisation, and in whom there is no reason to consider the use of oral prednisolone 40 mg daily for 5 days unsafe. At the same time, the relatively high dose used in this trial requires stringent exclusion criteria to ensure patient safety.
The eligibility criteria are as follows:. In the past 24 hours, the patient has had at least one of the screening symptoms listed below a-d , localising to the lower respiratory tract and suggestive of an acute LRTI:. Patient and practice have sufficient time for consent and randomisation into the trial by the end of the day of consultation, or the next working day as long as this is within 24 hours;. Patient able, willing and available to receive weekly telephone calls from the trial team.
The presence of any of the following exclusion criteria warrants exclusion:. Known lung cancer or chronic lung disease for example, cystic fibrosis, COPD, bronchiectasis ;. According to NICE guidelines, the patient warrants immediate antibiotic treatment by virtue of one or more of the following:.
Is at high risk of complications, including patients with chronic heart, chronic lung for example, COPD, bronchiectasis and cystic fibrosis , chronic renal, chronic liver or neuromuscular disease or immunosuppression; or with complications from previous episodes of lower respiratory tract infection, for example hospital admission for pneumonia. Aged over 65 years with at least two of the following criteria, or aged over 80 years with at least one of the following criteria:. Requires an oral or systemic antibiotic on the day of consultation to treat another infection unrelated to their acute cough, for example a co-existing cellulitis note: use of topical antibiotics does not preclude OSAC trial participation ;.
Known to be pregnant, is trying to conceive or is at risk of pregnancy for example, unwilling to take a reliable form of contraception in the next month;. Has been involved in another medicinal trial within the last 90 days or any other clinical research study within the last 30 days;.
Is unable to give informed consent or complete the trial paperwork including the symptom diary through mental incapacity, for example major current psychiatric illness, learning difficulties and dementia;. Known immune-deficiency, for example chemotherapy causing immunosuppression, asplenia or splenic dysfunction, advanced cancer or HIV infection;.
Patient due to receive the shingles vaccine in conjunction with the influenza vaccine;. Known allergy to prednisolone or other OSAC trial tablet ingredients potato starch, lactose monohydrate, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate , galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Intention to use a live vaccine in the next 8 weeks or has received a live vaccine in the previous 2 weeks note: assess live vaccine status by cross-checking with the British National Formulary.
To meet the recruitment target and to ensure a generalisable patient population, recruitment will take place across four collaborating UK trial centres: the Universities of Bristol, Nottingham, Oxford and Southampton. Participants may stop taking the trial medication before the 5 days if they feel completely better for two consecutive days. Participants, clinicians and the trial team including the statisticians will all be blinded to allocation.
All participants randomised to the trial will continue to receive usual clinical care. The computer-generated randomisation schedule will be produced by a statistician who is independent of the OSAC trial statisticians, and stratified by centre using a variable block size. Packs, which are indistinguishable between active and placebo groups, are issued sequentially to eligible, consented patients at recruiting primary care sites.
Clinicians, patients and all members of the research team were masked to the randomisation sequence, and all outcome data were gathered masked to allocation status. The use of distinct Participant ID and Medicine ID numbers will enable flexibility in the number of patients recruited at each of the four trial centres. Medicine packs can be combined with patient packs as needed, allowing for temporary differential fluctuations in recruitment rates between centres. The four centres will be provided with Patient Packs to distribute to the participating primary care sites in blocks of four although larger numbers of packs will be issued to practices with proven capacity to recruit to this trial.
The Pharmacy will hold the master drug allocation log and provide a 24 hour emergency unblinding service based on a standard operating procedure for breaking the code in the event of a medical emergency. Trial participants will be given a Trial Participation Card with details of who their Responsible Clinician should contact in the event of an emergency, and all practice-based clinicians will receive training in the use of the emergency unblinding service.
At the end of the trial, the code-break will only be released to the investigative team once written confirmation has been received that primary outcome data analysis is complete. The OSAC trial will use validated patient completed symptom diary methods [ 37 ] that have been used in a number of similar previous trials [ 2 , 5 ].
Participants will record in the diary the severity of the following symptoms: cough; phlegm; shortness of breath; sleep disturbance; feeling generally unwell; activity disturbance. For this trial, we will record all the above symptoms for up to 28 days or until symptom resolution for two consecutive days since LRTI duration has been previously shown to last 3 to 4 weeks [ 5 ]. Cough duration and severity will be measured for up to 8 weeks since effects on these may not be apparent for some time after using corticosteroids.
Duration is calculated as the number of days from randomisation to the last day that the participant scored 3 or higher, where that last day is followed by at least two consecutive days where the score is less than 3;. Mean of all symptom severity scores on days 2 to 4 post randomisation, measured using the symptom diary. Severity of symptoms is scored 0 to 6 as for cough, detailed above.
A mean score will be calculated across these symptoms for each of days 2, 3 and 4 and then an overall mean calculated. Patient satisfaction with treatment and intention to use the same treatment if it were to be available in the future;. Clinical diagnosis of asthma, COPD, whooping cough pertussis , or lung cancer at 3 months;. NHS treatment and investigation costs, out-of-pocket patient and family costs, and the cost to society of time off work.
Since the distributions of both primary outcome variables the duration of moderately bad or worse cough and the mean severity score of all its associated symptoms on days 2 to 4 post-randomisation will be positively skewed, sample size calculations are based on the log-normal distribution. The mean standard deviation SD duration of bad or moderately worse cough was taken from a previous study examining the effectiveness of prescribed antibiotics for acute LRTI [ 5 ] and estimated as 5.
The mean SD symptom severity score between days 2 and 4 taken from the same trial was estimated as 2. Using standard formulae for the mean and standard deviation of a log-normal distribution, this corresponds to 1. Therefore, since duration of cough lasts significantly longer than the period during which severity of symptoms are measured days 2 to 4 and is capturing an element of the illness severity, duration of moderately bad or worse cough might be viewed as the slightly more clinically important outcome.
Hence a total sample size of is required. The trial team will make all efforts to recruit the participants. If recruitment is slower than anticipated, recruitment will be extended until at least have been recruited to each arm in total.
Placebo tablets will be manufactured by Piramal Healthcare Ltd Morpeth UK to exactly match the prednisolone tablets in dimensions, appearance and taste, to maintain allocation blinding. A minimum of 60 GP practices will be recruited to take part in the trial across the four trial centres, with a wide geographical spread in both urban and rural areas across the South West, Midlands and North West of England. The number recruited will take account of anticipated ready to recruit open to actually recruiting active ratios.
If the patient is willing, the clinician will screen the patient for eligibility. The routine clinical management of the patient will be completed as normal. A requirement for immediate antibiotic treatment renders the patient ineligible. The patient is then referred to a further interview for full recruitment and trial entry.
The recruitment interview must take place on the same, or next, day as the routine consultation. Same-day recruitment will be more efficient for many patients who may not wish to return to the GP practice again the following day. Same-day recruitment will also help ensure that participants take the first dose of their trial medication prior to collecting any delayed antibiotic that may have been prescribed for them by their GP, thereby ensuring the validity of antibiotic consumption as one of the secondary outcome measures.
Some patients may wish to start taking a treatment on the same day that they visit the GP practice, and in the absence of a trial treatment those patients may be more likely to take antibiotics obtained from a delayed prescription or visited another healthcare provider while waiting for the next day to enter the trial. However, if the site or patient do not have time for the recruitment interview on the same day, the patient can be recruited on the following working day, if the following conditions are met: the recruitment interview is not deferred to the Monday following a weekend, to reduce the possibility of recruiting patients whose clinical condition has deteriorated significantly since the eligibility assessment was performed; and any delayed antibiotic prescription is post-dated by at least 24 hours after the recruitment interview, to ensure that the patient has the opportunity to take the first dose of their trial medication prior to collecting their delayed antibiotic prescription.
The Recruiting Clinician will take formal written consent, collect the remaining CRF data including symptoms, signs and respiratory history , issue the patient with the trial medicines and explain how to take them. The patient will also receive a symptom diary, peak flow meter and other materials to fully equip them for the follow-up, and training in how to measure peak expiratory flow and complete the diary. All follow-up will be managed by the trial team, who will give participants individual support throughout their follow-up period.
Participants will complete the symptom diary online or on paper every day for up to 28 days or until symptoms have been completely resolved for two consecutive days whichever is soonest. As well as recording the severity of their symptoms, completing the symptom diary includes recording peak flow measurements and whether or not any antibiotics have been taken.
The patient will also record how many of the trial tablets they took on days 1 to 5, and any adverse effects during the first 7 days. All participants will be telephoned within the first 2 days of trial entry, and then each week for 4 weeks to support symptom diary completion, collect the daily data they have recorded during the preceding week to safeguard against potential loss of data if paper diaries are not returned to the trial centre or there are problems with the post , and to collect the weekly data on resource use and quality of life measures.
The patient will not be asked to complete any further trial paperwork after the initial 28 day period. This data collection will take place at least 4 months after randomisation to allow for secondary care contacts and test results to be evident in the primary care notes. See Figure 1 study flow chart for a visual representation of the pathway of the trial participant through the trial presentation, index consultation, baseline recruitment interview, and follow-up. Study flow chart. A visual representation of the pathway of the trial participant through the trial presentation, index consultation, baseline recruitment interview, and follow-up.
Clinical data will be collected and managed using a secure, web-based system OpenClinica which will be developed, hosted and supported by the University of Oxford and validated by the University of Bristol. Patient confidentiality will be maintained at all stages of data collection. Participants will also be given the choice between online and paper data collection: the symptom diary will be made available online, with the exception of the EQ-5D-5L which will be completed by the patient on paper and also collected by the Trial Research Nurse during the weekly telephone calls.
Descriptive analyses will examine the comparability of the intervention and control group at baseline. The primary comparative analysis will be conducted on an intention-to-treat ITT basis. For the primary analysis missing data will be assumed to be missing at random and excluded from the analysis. Duration of cough is calculated as the number of days from the index consultation to the last day that the patient scored 3 or higher, where that last day is followed by at least two consecutive days with a score of less than 3.
Cox proportional hazards models adjusting by centre will be employed to examine differences in time to recovery from moderately bad to worse cough between the two groups. Individuals not recovered at 28 days post-randomisation will be censored at this time point. The assumption of proportional hazards will be checked using Schoenfeld residuals. Multiple linear regression models adjusting for centre will evaluate the effectiveness of steroids in terms of reducing symptom severity the mean score of six symptoms on days 2 to 4.
For both primary outcomes models will also adjust for any covariates demonstrating imbalance between the groups at baseline. Factors associated with missing data such as demographics and values of primary and important secondary outcome variables at baseline will be explored and sensitivity analyses conducted including inverse probability weights or multiple imputation methods, depending on whether outcome data is partially or fully missing. It is anticipated that not all participants will complete the full course of tablets; hence, in further sensitivity analysis a per-protocol analysis will be performed.
The economic analysis will use patient level data on participant resource use over the 28 day period between randomisation and the final follow-up telephone call. This will be compared with outcomes measured at the day follow-ups. The analysis will consider three perspectives: 1 the health care provider and personal and social services NHS and PSS ; 2 participants and their families, 3 societal cost of lost productivity due to time off work.
The costs associated with the NHS and PSS perspective will include: trial and prescription medication costs, and the costs associated with primary and secondary care consultations. Participant resource use will include travel to consultations, expenditure on over-the-counter medications, cost of extra domestic help and childcare, prescription payments, and loss of earnings.
We will use the data listed above to construct a cost-consequences matrix comparing cost from the three perspectives with the full range of primary and secondary outcomes. We will estimate incremental cost-effectiveness ratios comparing the extra cost, from the NHS perspective, of treating participants in the intervention group, with the extra benefit gained. Sensitivity analyses will be used to test the robustness of the results against assumptions made and bootstrapping will be used to estimate the level of uncertainty around the estimates of cost per QALY.
This paper describes a placebo-controlled, randomised multi-centre superiority trial that will establish the clinical and cost effectiveness of a commonly used treatment corticosteroids for an entirely novel indication and one of the commonest clinical problems managed in primary care: acute LRTI.
The trial will recruit between and non-asthmatic adult patients presenting to primary care with an acute cough of less than 28 days duration and at least one other lower respiratory tract symptom or physical examination finding. Participants will be telephoned weekly for 4 weeks, or until their cough resolves, up to a maximum of 8 weeks from recruitment. None of the sources of funding influenced either the trial design, the writing of the manuscript or the decision to submit the manuscript for publication.
Dr Birgit Whitman birgit. Competing interests. ADH is the Chief Investigator and guarantor of the trial, leads the development of the research question, trial design and implementation of the trial protocol for the investigative teams, and contributed to the drafting of the manuscript. MVM and AH contributed to the development of the research question and the trial design and, as Principal Investigators, supervised the implementation of the trial protocol in the Southampton and Oxford centres, respectively.
DK contributed to the development of the research question and the trial design, supervised the implementation of the trial protocol in the Nottingham centre as Principal Investigator, and contributed to the drafting of the manuscript. PL and MT contributed to the development of the research question and the trial design.
HED, the Trial Manager, coordinated the operational delivery of the trial protocol across the UK and contributed to the drafting of the manuscript. EO contributed to the trial design, to the supervision of trial implementation in the Nottingham centre, and to the drafting of the manuscript. DT co-ordinated the implementation of the trial in the Oxford centre and contributed to the drafting of the manuscript.
KW contributed to the trial design, to the supervision of trial implementation in the Oxford centre, and to the drafting of the manuscript. All authors listed provided critical review and final approval of the manuscript. Harriet E Downing, Email: ku. Fran Carroll, Email: ku. Sara T Brookes, Email: ku. Sandra Hollinghurst, Email: ku. David Timmins, Email: ku. Elizabeth Orton, Email: ku.