EUCTR2012-000851-15-GBActive, not recruitingPhase 1
What is the clinical and cost effectiveness of oral steroids in the treatment of acute lower respiratory tract infection (LRTI)? A placebo controlled randomised trial - The Oral Steroids for Acute Cough (OSAC) Trial
niversity of Bristol0 sites398 target enrollmentStarted: October 25, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 398
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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
- •The presence of any warrants exclusion: • Age <18 years or; • Patients unable to give informed consent or complete the trial paperwork, including the symptom diary, through mental incapacity, e.g. due to: o Major current psychiatric illness o Learning difficulties o Dementia or; • Patients unwilling to complete the trial symptom diary or unwilling to receive a weekly telephone call from the trial team; • Pregnant or intending to become pregnant (or unwilling to use reliable form of contraception) in the next month or; • Currently breast-feeding/lactating or; • Recruiting primary care site is not the patient's usual practice or if the patient is not expecting to still be with the primary care site in 3 months (i.e. temporary residents) or; • Patient has previously taken part in the OSAC trial or; • Involvement in another clinical drug trial in the last 90 days or any other respiratory related research within the last 30 days or; • Known immune-deficiency (e.g. HIV, active chemotherapy or advanced cancer) or; • Cough >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 <94%) or other systemic infection (e.g. suspected bacteraemia) or; • Patients at higher risk of complications, who according to NICE, warrant immediate antibiotic treatment (NB use of delayed prescription does not preclude OSAC trial participation). These include patients with: o Chronic heart, lung (e.g. chronic obstructive pulmonary disease, bronchiectasis and cystic fibrosis), renal, liver or neuromuscular disease or immunosuppression; or with complications from previous episodes of lower respiratory tract infection (e.g. hospital admission for pneumonia) or; o Patients older than 65 years with two or more of the following criteria, or older than 80 years with one or more of the following criteria: • Unplanned hospitalisation in previous year, • Type 1 or type 2 diabetes • History of cardiac failure • Unable to complete recruitment process by the end of the day of presentation or; • Recent (=1 month) use of any inhaled corticosteroids or; • Recent (=1 month) use of any short course (?1 week) systemic corticosteroids or; • Current or previous (=12 months) long term (= 1 week course) use of systemic steroids or; • Known contra-indications or cautions to oral steroids including: o Uncontrolled diabetes (HbA1c >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
Investigators
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