Chronic obstructive pulmonary disease. MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Prednisolone 30mg Tablets
Product Name: Prednisolone 30mg Tablets
Product Code: RVG 25347
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
Pharmaceutical form of the placebo:
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participant is willing and able to give informed consent for participation in the trial. • Male or Female, aged 40 years or above. • Diagnosed with COPD (primary or secondary care diagnosis) with spirometric confirmation of airflow obstruction (FEV1/FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range 114
Exclusion criteria
Exclusion criteria: • History of atopic childhood asthma • Current history of primary lung malignancy or current active pulmonary TB • Clinically relevant disease or disorder (past or present) which in the opinion of the investigator may either put the subject at risk because of participating in the study or may influence the results of the study or the subject’s ability to participate in the study. • Any clinically relevant lung disease, other than COPD considered by the investigator to be the primary diagnosis. For example mild-to-moderate bronchiectasis is acceptable in addition to COPD unless the bronchiectasis is considered to be the primary diagnosis. • An alternative cause for the increase in symptoms of COPD that are unrelated to an exacerbation such as i) suspicion or clinical evidence of pneumonia; ii) high probability and suspicion of pulmonary embolism; iii) suspicion or clinical evidence of a pneumothorax; iv) primary ischaemic event – ST or Non ST elevation myocardial infarct and left ventricular failure [i.e. not an exacerbation of COPD] • A known allergy to the IMP (prednisolone),NIMP (doxycycline) or to any of the constituents of the placebo • Patients on maintenance corticosteroids (prednisolone, hydrocortisone, fludrocortisone) • Known adrenal insufficieny • Currently enrolled in another CTIMP trial and receiving an intervention as part of the trial. • Pregnant and breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of blood-eosinophil directed corticosteroid therapy using near-patient testing, compared to current standard practice during an exacerbation of COPD.;Secondary Objective: To evaluate quality of life, symptoms, lung function and healthcare utilisation in a blood-eosinophil directed corticosteroid therapy arm. There is also an exploratory objective to evaluate the stability of blood eosinophils and mediators. ;Primary end point(s): The frequency of treatment non-responders, defined as those needing re-treatment, hospitalisation or death.;Timepoint(s) of evaluation of this end point: At 30 and 90 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in CAT health status, VAS symptom scores, EQ-5D, FEV1. 2. Frequency of moderate and severe exacerbations. 3. Change in blood eosinophil counts and mediatory levels (exploratory outcome) ;Timepoint(s) of evaluation of this end point: 1. Day 14, 30 and 90. 2. 12 months. 3. At all visits for blood eosinophil counts and at stable state and exacerbation for the inflammatory mediators (exploratory endpoints). | — |
Countries
United Kingdom
Contacts
Public ContactHania Piotrowska
Oxford Respiratory Trials Unit (ORTU)
Outcome results
None listed