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

June 29, 2012 updated by: Wilfried De Backer, University Hospital, Antwerp

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem (Antwerp), Antwerp, Belgium, B-2650
        • University Hospital of Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Inuvair
Drug: Inuvair
6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Peripheral airway resistance (from 4th bifurcation on) for the segmented airways
Time Frame: at baseline and after 6 months of treatment
at baseline and after 6 months of treatment
Total airway volume for the segmented airways
Time Frame: at baseline and after 6 months of treatment
at baseline and after 6 months of treatment
Peripheral airway volume (from the 4th bifurcation on) for the segmented airways
Time Frame: at baseline and after 6 months of treatment
at baseline and after 6 months of treatment
Relative compliance for each lobe
Time Frame: at baseline and after 6 months of treatment
at baseline and after 6 months of treatment
Density of the lung parenchyma given per predefined lung zone
Time Frame: at baseline and after 6 months of treatment
at baseline and after 6 months of treatment
Total airway resistance for the segmented airways
Time Frame: at baseline and after 6 months of treatment
at baseline and after 6 months of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BODE index
Time Frame: at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)

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)
at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)
COPD assessment test
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)
The COPD assessment measures the impact of COPD on a person's life.
at screening (visit 1), at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)
Borg CR10 Scale
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)
The Borg CR10 Scale measures the present dyspnea.
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)
Adverse events as a measure of safety
Time Frame: during the study patients will record record each day taken medication and any possible comments on the daily diary cards
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).
during the study patients will record record each day taken medication and any possible comments on the daily diary cards
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Antwerp

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chiesi Farmaceutici S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PML-DOC-1003
  • 2010-019864-36 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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