Open-label, prospective exploratory study to assess the effects of formoterol and beclometasone dipropionate combination therapy on central and peripheral airway dimensions in COPD patients.

niversity Hospital of Antwerp, Department of Respiratory Medicine0 个研究点开始时间: 2010年6月16日最近更新: 2017年8月21日

试验速览

暂无简介。

•1. Patients with documented COPD based on the following criteria:
•-Smoking history of at least 10 pack-years
•-Decreased Tiffeneau index: FEV1/FVC < 0.70
•2. Male or female patients aged = 40 years
•3. Patients who present
•-Moderate COPD with an FEV1 between 50 and 80% of predicted (GOLD 2)
•-Severe COPD with an FEV1 between 30 and 50% of predicted (GOLD 3)
•-Very severe COPD with an FEV1 lower than 30% of predicted (GOLD 4)
•4. Patients will be maintained on stable respiratory medications for 6 weeks prior to screening
•5. Patients with a co-operative attitude and ability to be trained to correctly use the pMDI
•6. Written informed consent obtained
•7. Patients should be treated according to GOLD guidelines, with a deviation for treatment of COPD GOLD 2 patients
•-FEV1 =60% predicted: treatment with inhalation corticosteroids (IHC) allowed.
•-FEV >60% predicted: IHC treatment allowed if exacerbation occurs after cessation of IHC treatment
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Pregnant or lactating females or females at risk of pregnancy
•2. Unstable patients who developed an exacerbation during the last 4 weeks
•3. Use of CPAP or BiPAP device
•4. Inability to carry out pulmonary function testing
•5. Diagnosis of asthma as defined by the current GINA guidelines
•6. Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
•7. Patients with a QTc interval (Bazett’s formula) at the screening visit ECG test >450 msec
•8. Cancer or any other chronic disease with poor prognosis and /or affecting patient status
•9. History of alcohol or drug abuse
•10. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
•11. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
•12. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
•13. Patients treated with any non-permitted concomitant medication

发起方

niversity Hospital of Antwerp, Department of Respiratory Medicine