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.

Phase 1

• Conditions: COPD (chronic obstructive pulmonary disease)

• Registration Number: EUCTR2010-019864-36-BE
• Lead Sponsor: niversity Hospital of Antwerp, Department of Respiratory Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-16
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified