search
Back to results

Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Inuvair
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Formoterol, Beclomethasone Dipropionate, Computational Fluid Dynamics, Functional Imaging, Central and Peripheral Airways, BODE index, COPD Assessment Test (CAT), Borg CR10 scale

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Antwerp

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Inuvair

Arm Description

Outcomes

Primary Outcome Measures

Peripheral airway resistance (from 4th bifurcation on) for the segmented airways
Total airway volume for the segmented airways
Peripheral airway volume (from the 4th bifurcation on) for the segmented airways
Relative compliance for each lobe
Density of the lung parenchyma given per predefined lung zone
Total airway resistance for the segmented airways

Secondary Outcome Measures

BODE index
The BODE index is a multidimensional index of disease severity . The index uses following parameters: body mass index (BMI) degree of airflow obstruction (Forced Expiratory Volume in 1 second (FEV1): % of predicted) functional dyspnea (Modified Medical Reseach Council (MMRC) dyspnea scale) exercise capacity (6 minute walk distance (6MWD) - m)
COPD assessment test
The COPD assessment measures the impact of COPD on a person's life.
Borg CR10 Scale
The Borg CR10 Scale measures the present dyspnea.
Adverse events as a measure of safety
During the study patients will record record each day taken medication and any possible comments on the daily diary cards. Further more, patients are contacted at least once a month (either by phone or at a visit in the hospital).
Forced expiratory volume in 1 second (FEV1)
Forced Vital Capacity (FVC)
Peak Expiratory Flow (PEF)
Maximum expiratory flow rate at 50% of vital capacity (MEF50)
Maximal expiratory flow rate at 25% of vital capacity (MEF25)
Vital capacity (VC)
Inspiratory vital capacity (IVC)
Functional residual capacity (FRC)
Total Lung Capacity (TLC)
Airway resistance (Raw)
Specific airways conductance (SGaw)

Full Information

First Posted
September 15, 2010
Last Updated
June 29, 2012
Sponsor
University Hospital, Antwerp
Collaborators
Chiesi Farmaceutici S.p.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT01204034
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inuvair
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Inuvair
Intervention Description
6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol
Primary Outcome Measure Information:
Title
Peripheral airway resistance (from 4th bifurcation on) for the segmented airways
Time Frame
at baseline and after 6 months of treatment
Title
Total airway volume for the segmented airways
Time Frame
at baseline and after 6 months of treatment
Title
Peripheral airway volume (from the 4th bifurcation on) for the segmented airways
Time Frame
at baseline and after 6 months of treatment
Title
Relative compliance for each lobe
Time Frame
at baseline and after 6 months of treatment
Title
Density of the lung parenchyma given per predefined lung zone
Time Frame
at baseline and after 6 months of treatment
Title
Total airway resistance for the segmented airways
Time Frame
at baseline and after 6 months of treatment
Secondary Outcome Measure Information:
Title
BODE index
Description
The BODE index is a multidimensional index of disease severity . The index uses following parameters: body mass index (BMI) degree of airflow obstruction (Forced Expiratory Volume in 1 second (FEV1): % of predicted) functional dyspnea (Modified Medical Reseach Council (MMRC) dyspnea scale) exercise capacity (6 minute walk distance (6MWD) - m)
Time Frame
at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)
Title
COPD assessment test
Description
The COPD assessment measures the impact of COPD on a person's life.
Time Frame
at screening (visit 1), at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)
Title
Borg CR10 Scale
Description
The Borg CR10 Scale measures the present dyspnea.
Time Frame
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)
Title
Adverse events as a measure of safety
Description
During the study patients will record record each day taken medication and any possible comments on the daily diary cards. Further more, patients are contacted at least once a month (either by phone or at a visit in the hospital).
Time Frame
during the study patients will record record each day taken medication and any possible comments on the daily diary cards
Title
Forced expiratory volume in 1 second (FEV1)
Time Frame
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)
Title
Forced Vital Capacity (FVC)
Time Frame
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)
Title
Peak Expiratory Flow (PEF)
Time Frame
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)
Title
Maximum expiratory flow rate at 50% of vital capacity (MEF50)
Time Frame
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)
Title
Maximal expiratory flow rate at 25% of vital capacity (MEF25)
Time Frame
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)
Title
Vital capacity (VC)
Time Frame
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)
Title
Inspiratory vital capacity (IVC)
Time Frame
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)
Title
Functional residual capacity (FRC)
Time Frame
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)
Title
Total Lung Capacity (TLC)
Time Frame
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)
Title
Airway resistance (Raw)
Time Frame
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)
Title
Specific airways conductance (SGaw)
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried A De Backer, MD PhD
Organizational Affiliation
University Hospital of Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Antwerp
City
Edegem (Antwerp)
State/Province
Antwerp
ZIP/Postal Code
B-2650
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

We'll reach out to this number within 24 hrs