Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Trade Name: Symbicort Turbohaler 320/9 micrograms/ inhalation
Product Name: Symbicort Turbohaler 320/9 micrograms/ inhalation
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: budesonide
CA
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria-Healthy non-smokers • Non-smoking volunteer • aged 40 –75 years (age matched to COPD patients) • Normal spirometry (normal FEV1/FVC ratio >70% and FEV1>80% predicted) • Subjects are able to give informed consent Inclusion Criteria-COPD patients (stage II-III according to the GOLD guidelines13) • Current and/or ex-smokers with no less than 10 pack-year smoking history • aged 40 –75 years • FEV1 bigger than or equal to 30% and less than 80% of predicted (the upper value is a prostbronchodilator value) • FEV1/FVC =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria-Healthy non-smokers • Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator • Upper respiratory infection within the last 4 weeks • Subjects who have received research medication within the previous one month • Subjects unable to give informed consent • Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study. Exclusion Criteria-COPD patients • Evidence of asthma • Bronchodilator reversibility > 12% • Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator • Patients who have had oral steroids within 8 weeks prior to the screening visit. • Patients who are already on ICS and in which it is considered unsafe (as judged by the Investigator) to stop this treatment for the study period. • Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the screening visit. • Upper respiratory infection within the last 4 weeks • Subjects who have received research medication within the previous one month • Subjects unable to give informed consent • Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study • Patients with significant co-morbidities as judged by the investigator • Any other respiratory disease, which is considered by the investigator to be clinically significant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate effect of Symbicort on HDAC and HAT activities ratio in macrophages of induced sputum in COPD patients in comparison with the effect Pulmicort (budesonide) and placebo treatment.;Secondary Objective: Several inflammation or anti-inflammation markers and lung function will be evaluated as shown below Induced sputum Cells: o Differential cell counts o HDAC-1,-2,-5, HAT and CREB binding protein (CBP) mRNA expression by Quantitative RT-PCR o GRE and NF-kB activity by TransAM method o mRNA expression of IL-8, MCP-1, GRO-alpha and MMP9 if enough sample has been obtained (see 8.6) Supernatant: o IL-8, MCP-1, GRO-alpha (ELISA) o MMP9 activity (Fluorometric assay) Exhaled breath condensate 8-isoprostane, LTB4 (ELISA) Exhaled Nitric Oxide (NO) using the multiple expiratory flow technique to measure peripheral production of NO Lung function (Spirometry -FEV1, FVC, FEV1/FVC) Impulse oscillometry (IOS)- 4 tests (each one lasting 1 minute) ;Primary end point(s): HDAC and HAT activity ratio | — |
Countries
United Kingdom
Outcome results
None listed