Chronic Obstructive Pulmonary DiseasePhase 3NCT01204034
Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Inuvair in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inuvair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital of Antwerp
Edegem (Antwerp), Antwerp, B-2650
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inuvair
- Keywords
- COPD, Formoterol, Beclomethasone Dipropionate, Computational Fluid Dynamics, Functional Imaging, Central and Peripheral Airways, BODE index, COPD Assessment Test (CAT), Borg CR10 scale
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InuvairDrug
6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol
| Study group | Role | What they receive |
|---|---|---|
| Inuvair | Other | Not described Receives: Drug: Inuvair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral airway resistance (from 4th bifurcation on) for the segmented airways
Measured: at baseline and after 6 months of treatment
Total airway volume for the segmented airways
Measured: at baseline and after 6 months of treatment
Peripheral airway volume (from the 4th bifurcation on) for the segmented airways
Measured: at baseline and after 6 months of treatment
Relative compliance for each lobe
Measured: at baseline and after 6 months of treatment
Density of the lung parenchyma given per predefined lung zone
Measured: at baseline and after 6 months of treatment
Total airway resistance for the segmented airways
Measured: at baseline and after 6 months of treatment
Secondary outcomes (15)
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)
Measured: at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)
COPD assessment test
The COPD assessment measures the impact of COPD on a person's life.
Measured: 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
The Borg CR10 Scale measures the present dyspnea.
Measured: 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
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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Principal investigator, Wilfried De Backer, University Hospital, Antwerp
- Investigators
- Wilfried A De Backer, MD PhD, Principal investigator, University Hospital of Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204034
- Sponsor's protocol ID
- PML-DOC-1003
- Other IDs
- 2010-019864-36
- Status last verified
- Jun 2012
- First submitted
- 15 Sep 2010
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01204034
- Acronym / sponsor ID
- PML-DOC-1003
- 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)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inuvair | Other | Drug: Inuvair |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inuvair6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol | Drug | Inuvair |
Primary outcome
Peripheral airway resistance (from 4th bifurcation on) for the segmented airways
Time frame: 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
Peripheral airway volume (from the 4th bifurcation on) for the segmented airways
Time frame: at baseline and after 6 months of treatment
Relative compliance for each lobe
Time frame: 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
Total airway resistance for the segmented airways
Time frame: at baseline and after 6 months of treatment
15 secondary outcomes
BODE index
Time frame: 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)
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried A De Backer, MD PhD principal investigator
University Hospital of Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inuvair in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral airway resistance (from 4th bifurcation on) for the segmented airways (time frame: at baseline and after 6 months of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.