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Cough variant asthma: usefulness of a diagnostic-therapeutic trial with prednisone.

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Prednisone bad cough. Coughing Sucks! What Can You Do To Treat Bronchitis? 













































   

 

- Coughing Sucks! What Can You Do To Treat Bronchitis? | Cirrus Medical Network



 

Trials volume 21Article number: Cite this article. Metrics details. Cough is a common reason for patients to visit general practices. It can be disabling in daily activities, with substantial impact on physical and psychosocial health, leading to impaired quality of life and increased health care costs. Recommendations for the management of post-infectious cough in primary care are scarce and incoherent.

A systematic review and meta-analysis of randomized clinical trials RCT assessing patient-relevant benefits and potential harms of available treatments identified six eligible RCTs assessing different treatment regimens i. No RCT found clear patient-relevant benefits and most had an unclear or high risk of bias.

Post-infectious cough is thought to be mediated by inflammatory processes that are also present in exacerbations of asthma or chronic obstructive pulmonary diseases for which there is strong evidence that oral corticosteroids provide patient-relevant benefit without relevant harm. We therefore plan to conduct the first RCT evaluating the effectiveness of oral corticosteroids for post-infectious cough.

We are conducting a triple-blinded randomized-controlled and multicentred superiority trial in primary health care practices in Switzerland. Participants will be randomly allocated to either the 5-day treatment with oral corticosteroids or placebo. Secondary outcomes include cough-related quality of life at several time points, overall cessation of cough and adverse events.

This RCT will provide evidence on whether oral corticosteroids are beneficial and safe in patients with post-infectious cough.

Results can have a substantial impact on the well-being and management of these patients in Switzerland and beyond. An evidence-based treatment for this condition may reduce re-consultations with GPs and spending for antitussive drugs, thus possibly having an impact on health care spending. Prospectively registered on 18 January Peer Review reports. Cough as a symptom of respiratory infections is frequent in primary care and is one of the most common causes to seek medical advice in general practices GP [ 1 ].

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 ]. Recommendations for the management of post-infectious cough in general practice are scarce and inconsistent [ 34 ].

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 ]. The review found only six RCTs assessing diverse treatment regimens, such as inhaled fluticasone propionate, inhaled budesonide, salbutamol plus ipratropium-bromide, montelukast, nociception-opioidreceptor agonist, codeine and gelatine.

Most of the studies included in the review had an unclear or high risk of bias [ 7 ]. Two RCTs assessed inhaled corticosteroids for post-infectious cough [ 89 ]. Pornsuriyasak et al. The trial by Ponsioen et al. Clinical guidelines and recommendations on the use of inhaled corticosteroids are unclear [ 3410 ]. A Cochrane review published in evaluated studies in which inhaled corticosteroids were tested in individuals with post-infectious or chronic cough [ 11 ].

A majority of the studies focused on patients with chronic cough and only two examined the benefits for post-infectious cough [ 11 ]. The authors concluded that no recommendation can be proposed due to the high heterogeneity and inconsistency of the studies and their results [ 11 ].

Additionally, an RCT in family practices in England found no benefit in terms of duration or severity of cough after a 5-day treatment with oral corticosteroids compared to placebo for adult patients with acute lower respiratory tract infection and without asthma [ 12 ]. Another RCT assessed the effectiveness of oral corticosteroids for patients with acute sore throat, Many of the symptoms in post-infectious cough are thought to be mediated by inflammatory processes that are also present in exacerbations of asthma or COPD [ 56 ].

However, at present, there is no established evidence-based treatment option for post-infectious cough, despite it being a very frequent condition. There is also considerable uncertainty regarding patient benefits from using inhaled or oral corticosteroids.

The systematic search of our group did not identify any published RCT that assessed short-term use of oral corticosteroids for post-infectious cough [ 7 ] we updated our search in October and still found no pertinent trial. We screened multiple study registries using the International Clinical Trials Registry Platform from the World Health Organization last search June and again found no trial investigating the use of oral corticosteroids for post-infectious cough.

A well-conducted randomized placebo-controlled trial is needed to determine the benefits and harms of using oral corticosteroids to treat post-infectious cough in patients in primary care. This randomized placebo-controlled trial aims to assess whether the benefits and harms of a 5-day prednisone treatment differ from those of a 5-day course of placebo. We designed a protocol for a randomized, parallel-group, placebo-controlled, triple-blinded, multicentred superiority trial in a primary health care setting, with blinded patients, physicians and outcome assessors.

Patients with post-infectious cough will be recruited by participating doctors in primary practices from cantons in the German-speaking part of Switzerland. Patient recruitment will continue until the sample size is reached. A list of the general practices currently taking part in the study can be obtained from the Sponsor-Investigator.

Known or suspected diagnoses associated with cough, such as pneumonia, allergic rhinitis, sinusitis, bronchial asthma, COPD, gastroesophageal reflux disease. Other chronic diseases such as bronchiectasis, cystic fibrosis, cancer, tuberculosis, heart failure.

Regular treatment known to be associated with cough e. Uncontrolled diabetes mellitus as deemed by GPs who appraise whether the potential side effects of short-time corticosteroids on glucose levels exceed the hypothesized benefit on cough. Patients with post-infectious cough presenting to their GP will be told about the OSPIC trial and provided with a study leaflet, participant information sheet and a consent form by their GP. They will be invited by the GP to take part after being given full written and verbal explanations of the trial purpose, potential benefits and risks and the procedures involved.

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. Participants will have sufficient time to ask questions and GPs will make sure to underscore that participation is voluntary and that declining to join the study does not influence in any way the standard of care provided to patients.

During the informed consent process with the GP, participants will be asked to give written permission for the storage and future use of the data resulted from the study. Placebo pills are described in detail in the next section.

Placebo will be used as a comparator in this study to prevent various biases in particular as the primary endpoint is patient-reported. Potential implications on a limited applicability of the results are acknowledged and will be discussed in the study results publication.

From an ethical point of view, an inactive control placebo seems justified since there is no established therapy for post-infectious cough and because the symptoms resolve over time due to the natural course of the disease [ 712 ].

The placebo tablets match in appearance, diameter and height the intervention medication. Verbal and written instructions on how the drugs should be taken will be provided to the study participants. Even though the likelihood is very low, adverse events AEsuch as allergic reactions to the study drug, psychotic or pre-psychotic episode, or serious adverse events SAEsepsis, venous thromboembolism, fracture, can occur [ 17 ]. In any of these cases, the treatment will be stopped immediately.

Medication will also be discontinued for other urgent reasons, such as pregnancy, a cancer diagnosis or an infection other than an upper respiratory tract infection. In order to facilitate adherence to the study intake schedule, participants are given a written medication guide.

GPs will inform patients in depth on the importance to adhere to the 5-day medication for ensuring the effectiveness of treatment. Furthermore, the dosing schedule is very convenient as the drugs need to be taken only once a day during breakfast and for a clearly defined and limited timeframe. In the event of a missed dose, patients are instructed to continue to take the medication the next day. Adherence to the study procedures will be checked at the follow-up phone call on day 7 from randomization when research staff will ask participants about their medication intake.

In case the study medication is prematurely stopped or discontinued patients are asked to return the empty drug glass jars to their GP. Apart from the use of corticosteroids, any co-treatment or co-medication i. Any other medical intervention used by study participants will be recorded in the electronic Case Report Forms eCRF to analyse the potential influence on outcomes.

Treating doctors can independently decide to change to open-label treatment, adjust medication if they deem it necessary and for the benefit of their patients or choose additional therapeutic options. All participants will be asked at follow-up about concurrent medication, including if they started a treatment with antibiotics. GPs and research staff are instructed to document time of onset, duration, resolution, actions to be taken, assessment of intensity and relationship with study treatment.

Participants will be advised that they need to use contraceptives for the duration of the treatment and that they should inform the GP or the study team in case they suspect they have become pregnant.

Women with anamnestic risk of a pregnancy unprotected sexual intercourse in the last 2 weeks shall be excluded from this study. If a participant will become pregnant during follow-up, the participant will visit her gynaecologist. The GP will document the course and the outcome of the pregnancy. Total and individual LCQ domain scores will be calculated. The LCQ is also suitable for capturing longitudinal developments in cough and cough-related well-being and can be useful in clinical trials assessing new medications for cough [ 20 ].

Appointments for the next phone calls will be set during the previous phone call and will assess:. Changes in glucose levels for patients with pre-study controlled diabetes that are deemed by GP to exceed the hypothesized benefit on cough. Continuous outcomes will be assessed by comparing mean values. Medians will be considered in addition if we identify severe departures from normal distribution. Eligible patients who consent to the study will be randomly assigned by their GP to the active treatment or the control group.

If performed, the GP will also record diagnostic test results. Participants will be asked to complete the standardized LCQ questionnaire and hand it to the GP on day 0. Participants will also be informed about the follow-up calls and that the next telephone appointment will be at day 7 of the trial. After inclusion in the study, it is at the discretion of the treating GP to re-assess each participant at the general practice, when and as often as clinically needed.

Physical examinations, lab testing, performing X-rays e. In case participants are not reached at the first call, follow-up phone calls will be performed several times and participants will be sent reminders by email. Study schedule.

To be able to detect an MCID of 1. Due to the fact that the number of recruited patients per GP is limited to 10, ICC might remain small. Sample size estimation was based on the assumption that individual LCQ scores are normally distributed. Raj et al. A recent trial with a design and study population similar to ours reported a SD of 2. We decided to use the more conservative assumption of 3. A less conservative choice of an SD of 2. To compute the t test, the current version of the R language and environment R Foundation, www.

In case of recruitment difficulties due to scheduled numbers of participants not being reached at predefined milestones, the limit of maximum of 10 randomized patients per GP can be increased.

❿  


Prednisone bad cough. Cough variant asthma: usefulness of a diagnostic-therapeutic trial with prednisone



  This randomized trial compares the effect of prednisolone vs placebo on duration of moderately bad or worse cough and severity of symptoms in nonasthmatic. After a diagnostic-therapeutic trial with prednisone, nine patients reported significant improvement of cough in three days. One patient required 2 weeks of.     ❾-50%}

 

Prednisone bad cough



    Cochrane Database Syst Rev. Inhaled corticosteroids such as Qvar, Pulmicort, Flovent and others are generally indicated for long term management of inflammatory lung conditions like asthma and COPD. Readers' comments will be moderated - see our guidelines for further information. Potential side effects from corticosteroids are typically more apparent when they are used at higher doses or for extended periods of time. It will be based on the full analysis set FAS which will include all patients who were randomized and gave informed consent. In case participants are not reached at the first call, follow-up phone calls will be performed several times and participants will be sent reminders by email. Maybe you are experiencing some of the "red flags" described above or you are basically at your wits end?

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Story by: Menisa Marshall on September 19, I was awake and coughing my head off. It felt like a giant hair ball was stuck in my lungs, but no amount of hacking would dislodge it. The good news is I had no body aches or fever.

The bad news is I knew I faced two to three weeks of constant coughing and sleepless nights. It was bronchitis. She was surprised to be prescribed steroids — a first for her that raised some concerns given the negative things you hear about them.

But they worked well and her coughing improved dramatically by the next day. According to James Jennings, M. Jennings said. Fortunately, my recent bronchitis saga took a happy turn thanks in part to steroids. By that Saturday morning I was being seen by a physician who assessed my breathing, temperature, history and other key medical indicators.

The diagnosis, as expected, was allergy-induced bronchitis. We talked about treatment options and outcomes. I left with prescriptions for a one-week supply of corticosteroids prednisonea two-week supply of allergy medicine and codeine cough syrup a virtual lifesaver!

I got the medications on the way home and began taking them that day. By Sunday afternoon I was doing measurably better. By Monday, I was at work with very little coughing. The biggest takeaway from my experience is not to make assumptions about your medical care and what you think you know. How can you know what care options are available unless you seek professional medical help? If you need medical care, visit one of 13 convenient Norton Immediate Care Centers.

Most are open seven days a week, 9 a. Are they safe for bronchitis, asthma, arthritis? Late on a recent Friday evening I felt a bit congested, and my throat had a familiar tickle. In broad terms, there are three things people should understand about steroids: There is a marked difference between anabolic steroids and corticosteroids. Anabolic steroids include testosterone and synthetic lab made substances that mimic testosterone.

Corticosteroids are anti-inflammatory medications prescribed by physicians as medical treatment for a variety of conditions. Corticosteroids can have many side effects that can range from mild to serious. Common side effects may include weight gain or swelling, puffy face, headache, muscle weakness, poor diabetes control, glaucoma and cataracts. Potential side effects from corticosteroids are typically more apparent when they are used at higher doses or for extended periods of time.

These powerful medications should always be used as directed by a physician. Schedule an Appointment Select an appointment date and time from available spots listed below.

This randomized trial compares the effect of prednisolone vs placebo on duration of moderately bad or worse cough and severity of symptoms in nonasthmatic. After a diagnostic-therapeutic trial with prednisone, nine patients reported significant improvement of cough in three days. One patient required 2 weeks of. The bad news is I knew I faced two to three weeks of constant coughing and sleepless nights. It was bronchitis. The team found there was no reduction in the duration of cough, at their most severe) in the prednisolone group compared with the. * Prednisone. Ok, most doctors would say these should ONLY be taken as prescribed by your doctor. These steroids are pure anti-inflammatories, used for just. What is the minimal important difference for the Leicester Cough Questionnaire? No RCT found clear patient-relevant benefits and most had an unclear or high risk of bias. Some patients had significant side effects from coughing including interference with social life, work and sleep, urinary incontinence, stool incontinence, hoarseness, and vomiting. Study results will be published in a peer-reviewed medical journal, independent of the outcomes and conclusions.

Cough variant asthma is characterized as a persistent, nonproductive cough with minimal or no wheezing and dyspnea. The diagnosis can be overlooked or misdisagnosed. We describe the severity of cough, the misery of some patients who have this syndrome and the usefulness of a diagnostic-therapeutic trial in ten patients with cough variant asthma. We evaluated ten patients whose chief complaint was persistent nonproductive cough.

During the course of evaluation, all patients received a diagnostic-therapeutic trial of prednisone for cough variant asthma after other major causes of cough had been excluded.

The duration of cough ranged from 2 months to 20 years. Some patients had significant side effects from coughing including interference with social life, work and sleep, urinary incontinence, stool incontinence, hoarseness, and vomiting. After a diagnostic-therapeutic trial with prednisone, nine patients reported significant improvement of cough in three days. One patient required 2 weeks of therapy for optimal improvement. All were subsequently controlled primarily with inhaled conticosteroids.

The diagnosis of cough variant asthma may not be made for a prolonged time. A short course of prednisone as a diagnostic-therapeutic trial can establish a diagnosis and be followed by an effective method of control of cough by inhaled corticosteroids.

Abstract Cough variant asthma is characterized as a persistent, nonproductive cough with minimal or no wheezing and dyspnea. Gov't Research Support, U. Gov't, P. Substances Prednisone.



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