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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-000851-15
    Sponsor's Protocol Code Number:UoB1581
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-000851-15
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.3.2Name or abbreviated title of the trial where available
    The Oral Steroids for Acute Cough (OSAC) Trial
    A.4.1Sponsor's protocol code numberUoB1581
    A.5.4Other Identifiers
    Name:NHS RECNumber:12/SW/0180
    Name:EudraCTNumber:2012-000851-15
    Name:NIHR CSPNumber:102138
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Bristol
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR School for Primary Care Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Bristol
    B.5.2Functional name of contact pointBirgit Whitman
    B.5.3 Address:
    B.5.3.1Street AddressResearch and Enterprise Development
    B.5.3.2Town/ citySenate House, Tyndall Avenue
    B.5.3.3Post codeBS8 1TH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01173317130
    B.5.5Fax number01179298383
    B.5.6E-mailbirgit.whitman@bristol.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Prednisolone
    D.2.1.1.2Name of the Marketing Authorisation holderGALENpharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePrednisolone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 50-24-8
    D.3.9.3Other descriptive name11-BETA, 17-ALPHA, 21-HYDROXY-1, 4-PREGNADIENE-3, 20-DIONE
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute lower respiratory tract infection/bronchitis
    E.1.1.1Medical condition in easily understood language
    Acute bronchitis / chest infection
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006451
    E.1.2Term Bronchitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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?
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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 Intention to use a live vaccine in the next 3 months o Cardiac failure o Renal impairment o Liver failure o Patients taking other interacting medication (e.g. phenytoin and anti-coagulants) o Any other BNF listed contra-indication Clinicians will be asked to use the British National Formulary (BNF) and their clinical prescribing systems to check for significant interactions for all patients. A SOP will be produced to describe the checking process.
    E.5 End points
    E.5.1Primary 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).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Daily scores, for up to 28 days 2. Daily scores, days 2 to 4
    E.5.2Secondary 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).
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned60
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will occur when the data analysis is complete.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 392
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state436
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment will not differ from usual care following trial participation.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation None involved
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-24
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