Acute lower respiratory tract infection/bronchitis MedDRA version: 14.1 Level: PT Classification code 10006451 Term: Bronchitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Prednisolone
Product Name: Prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All must apply: • Adults (=18 years) presenting to primary care (general practices) requesting advice for an acute (28 days) cough as the main symptom and; • At least 1 symptom localizing to the lower respiratory tract and suggestive of an acute lower respiratory tract infection (sputum, chest pain, shortness of breath, wheeze) and; • Patient’s first time in the OSAC trial and; • Patient and primary care site are able to consent and randomise the patient by the end of the (working) day of presentation and; • Patient is immunocompetent and; • Patient has capacity and willingness, in the view of the recruiting clinician, to give informed consent and complete the trial paperwork, including the symptom diary, and; • Patient is willing to receive a weekly telephone call from the trial team. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 392 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: The presence of any warrants exclusion: • Age 28 days or; • No lower respiratory tract symptoms or signs (sputum, chest pain, shortness of breath, wheeze) or; • Patients with an 'active' diagnosis of asthma (for which treatment has been given in the past 2 years) or; • Patients without a definite history of chickenpox and a recent (= 28 days) history of close personal contact with chickenpox or herpes zoster or; • Unable to swallow tablets or; • Clinically very unwell or with symptoms and signs suggestive of pneumonia (as per the British Thoracic Society Guidelines e.g. tachypnoea, unilateral chest signs of consolidation or hypoxia (oxygen saturation 8%) o Peptic ulcer disease o Previous TB o Known allergy to Prednisolone or other tablet ingredients (potato starch, lactose monohydrate, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate), galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption o Suspected ocular herpes simplex o Cushing’s disease o Osteoporosis o Uncontrolled hypertension o Severe affective disorders (e.g. manic depression, previous steroid psychosis) o Glaucoma o Previous steroid myopathy o Epilepsy o Intenti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does the use of oral prednisolone reduce the duration of moderately bad or worse cough and / or the severity of all its associated symptoms on days 2 to 4 by at least 20% when compared to no steroid treatment in adults =18 years presenting to primary care with acute LRTI?;Secondary Objective: In relation to the use of oral steroids compared with no steroid treatment for acute LRTI, we will also: 1. Assess the effects on antibiotic consumption 2. Estimate the cost-effectiveness from the perspectives of the NHS, patients, and society 3. Compare the burden, severity and duration of abnormal peak flow and the following symptoms: cough until 'very little problem'; phlegm; wheeze; fever; chest pain; shortness of breath; sleep disturbance; activity disturbance; and feeling generally unwell 4. Compare adverse events, including reconsultations for documented illness deterioration or hospital admission 5. Investigate if patients’ subjective or objective response to oral steroids is associated with a clinical diagnosis of asthma or COPD 6. Assess patients' satisfaction with treatment and their intention to consult for future similar illnesses.;Primary end point(s): 1. Duration of moderately bad or worse cough (using a validated web/paper based symptom diary) 2. The mean of all symptom severity scores on days 2 to 4 (where day 1 is the day of the index consultation, measured using the symptom diary).;Timepoint(s) of evaluation of this end point: 1. Daily scores, for up to 28 days 2. Daily scores, days 2 to 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. Up to 28 days 2. Up to 5 days 3. Up to 28 days 4. Up to 28 days 5. = 28 days 6. 3 months 7. Up to 28 days 8. Up to 28 days;Secondary end point(s): 1. Antibiotic consumption (symptom diary) 2. Duration of steroid tablet use (symptom diary) 3. Total duration and severity of other symptoms (cough until very little problem; phlegm; wheeze; fever; chest pain; shortness of breath; sleep disturbance; activity disturbance; and feeling unwell) and abnormal peak flow (symptom diary) 4. Adverse events including reconsultation for a documented illness deterioration (symptom diary and primary care notes review) 5. Patient satisfaction with treatment and intention to consult for future similar illnesses (symptom diary) 6. Clinical diagnosis of asthma at 3 months (primary care notes review) 7. Quality of life using the EQ-5D (as recommended by NICE, symptom diary) 8. NHS treatment and investigation (e.g. chest x-rays, reconsultation) costs (primary care notes review), out-of-pocket patient costs, and societal cost of time off work (symptom diary). | — |
Countries
United Kingdom
Contacts
Public ContactBirgit Whitman
University of Bristol
Outcome results
None listed