Clinical trial NCT01204034: Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Formoterol
Beclomethasone Dipropionate
Computational Fluid Dynamics
Functional Imaging
Central and Peripheral Airways
BODE index
COPD Assessment Test (CAT)
Borg CR10 scale
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2010-09-17
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT) and Borg CR10 scale will be assessed and the safety will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with documented COPD based on the following criteria:

Smoking history of at least 10 pack-years Decreased Tiffeneau index: FEV1/FVC \< 0.70

* Male or female patients aged ≥ 40 years
* Patients should be treated according to the 'Global initiative for chronic Obstructive Lung Disease' (GOLD) guidelines
* 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)
* Patients will be maintained on stable respiratory medications for 6 weeks prior to screening
* Patients with a co-operative attitude and ability to be trained to correctly use the pMDI
* Written informed consent obtained

Exclusion Criteria:

* Pregnant or lactating females or females at risk of pregnancy
* Unstable patients who developed an exacerbation during the last 4 weeks
* Inability to carry out pulmonary function testing
* Diagnosis of asthma as defined by the current 'Global Initiative for Asthma' (GINA) guidelines
* 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
* Patients with a QTc interval (Bazett's formula) at the screening visit electrocardiogram (ECG) test \>450 msec
* Cancer or any other chronic disease with poor prognosis and /or affecting patient status
* History of alcohol or drug abuse
* Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
* Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
* Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
* Patients treated with any non-permitted concomitant medication

Primary outcomes:
measure: Peripheral airway resistance (from 4th bifurcation on) for the segmented airways
timeFrame: at baseline and after 6 months of treatment
measure: Total airway volume for the segmented airways
timeFrame: at baseline and after 6 months of treatment
measure: Peripheral airway volume (from the 4th bifurcation on) for the segmented airways
timeFrame: at baseline and after 6 months of treatment
measure: Relative compliance for each lobe
timeFrame: at baseline and after 6 months of treatment
measure: Density of the lung parenchyma given per predefined lung zone
timeFrame: at baseline and after 6 months of treatment
measure: Total airway resistance for the segmented airways
timeFrame: at baseline and after 6 months of treatment
Secondary outcomes:
measure: BODE index
timeFrame: at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)
measure: COPD assessment test
timeFrame: at screening (visit 1), at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)
measure: Borg CR10 Scale
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Adverse events as a measure of safety
timeFrame: during the study patients will record record each day taken medication and any possible comments on the daily diary cards
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Forced Vital Capacity (FVC)
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Peak Expiratory Flow (PEF)
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Maximum expiratory flow rate at 50% of vital capacity (MEF50)
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Maximal expiratory flow rate at 25% of vital capacity (MEF25)
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Vital capacity (VC)
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Inspiratory vital capacity (IVC)
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Functional residual capacity (FRC)
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Total Lung Capacity (TLC)
timeFrame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Airway resistance (Raw)
timeFrame: At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
measure: Specific airways conductance (SGaw)
timeFrame: At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)
Other outcomes:
Locations:
city: Edegem (Antwerp)
country: Belgium
facility: University Hospital of Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital of Antwerp
name: Wilfried A De Backer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: