AsthmaPhase 4NCT00910793
Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Asthmatic Patients
A Phase 4 study testing Inuvair in people with Asthma, run by Wilfried De Backer 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 asthmatic patients using Computational Fluid Dynamics (CFD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- 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
- Aug 2008to Aug 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with asthma as defined by the current Global INitiative for Asthma (GINA) guidelines:
- Male or female patients aged ≥18 years
- Patients with a documented positive response to the reversibility test within the 12 months preceding the screening visit or performed at screening visit after a wash-out of 2 days for long acting β2 agonists or a documented positive response to the methacholine challenge test
- Patients with a co-operative attitude and ability to be trained to correctly use the pressurized Metered Dose Inhaler (pMDI)
- Written informed consent obtained
Who cannot join
- Pregnant or lactating females or females at risk of pregnancy
- Inability to carry out pulmonary function testing
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines
- History of near fatal asthma
- Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
- Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day
Show all 14Show fewer
- 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 8 weeks prior to the screening visit
- Patients treated with any non-permitted concomitant medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Prospective Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in Asthmatic 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 asthmatic patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on exhaled NO, lung function (spirometry, body plethysmography, diffusion and resistance) and subjective asthma control score as well as the safety of this combination will be assessed.
- Conditions
- Asthma
- Being tested
- Inuvair
- Keywords
- Asthma, Formoterol, Beclomethasone Dipropionate, Computational Fluid Dynamics, Functional Imaging, Central and Peripheral Airways
- Medical subject headings
- Asthma
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.
Differences in airway dimension
The primary objective of this study is to evaluate the effect of the combination therapy on central and peripheral airway dimensions with CFD. The following primary outcome parameters will be determined:
- Total airway resistance for the segmented airways
- 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
Measured: airway dimension will be measured at visit 2 and visit 7
Secondary outcomes (4)
Lung function tests: dynamic lung volumes, static lung volumes and airway resistances
The secondary outcome parameters that will be obtained with the lung function tests are:
- Dynamic lung volumes: Forced Expiratory Volume in 1 sec (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF),Maximum expiratory flow when 50% of the FVC remain to be exhaled (MEF50) , Maximum expiratory flow when 25% of the FVC remain to be exhaled (MEF25)
- Static lung volumes: Vital Capacity (VC),Inspiratory Vital Capacity (IVC), Functional Residual Capacity (FCR), Total Lung Capacity (TLC)
- Airway resistances: Airway Resistance (Raw), Specific Airway Conductance(SGaw) (based on body plethysmography)
Measured: lung function tests will be perfomed at te following visits: screening, visit 1 (2 weeks after screening), visit 3 (6 weeks after screening), visit 5 (14 weeks after screening) and visit 7 (26 weeks after screening)
Subjective asthma control score
Asthma control scores will be obtained with the Dutch Asthma Control Test.
Measured: Asthma Control Test (ACT) will be performed on visit 1, 2, 3, 5 and 7
Exhaled Nitric Oxide (NO)
Measured: Exhaled NO will be measured on visit 2, 3, 5 and 7
Adverse events as a measure of safety
Measured: Follow up of adverse events will be done during the entire study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilfried De Backer
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor-investigator, Wilfried De Backer, University Hospital, Antwerp
- Investigators
- Wilfried A De Backer, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910793
- Sponsor's protocol ID
- PML_DOC_0802
- Other IDs
- Eudract number: 2008-002391-97
- Status last verified
- Jul 2013
- First submitted
- 28 May 2009
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Prospective Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT00910793
- Acronym / sponsor ID
- PML_DOC_0802
- Conditions
- Asthma
- Keywords
- Asthma, Formoterol, Beclomethasone Dipropionate, Computational Fluid Dynamics, Functional Imaging, Central and Peripheral Airways
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Wilfried De BackerUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Aug 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Jun 2009 (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 asthmatic patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on exhaled NO, lung function (spirometry, body plethysmography, diffusion and resistance) and subjective asthma control score as well as the safety of this combination will be assessed.
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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with asthma as defined by the current Global INitiative for Asthma (GINA) guidelines:
- Male or female patients aged ≥18 years
- Patients with a documented positive response to the reversibility test within the 12 months preceding the screening visit or performed at screening visit after a wash-out of 2 days for long acting β2 agonists or a documented positive response to the methacholine challenge test
- Patients with a co-operative attitude and ability to be trained to correctly use the pressurized Metered Dose Inhaler (pMDI)
- Written informed consent obtained
Key exclusion criteria (14 listed)
- Pregnant or lactating females or females at risk of pregnancy
- Inability to carry out pulmonary function testing
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines
- History of near fatal asthma
- Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
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
Differences in airway dimension
Time frame: airway dimension will be measured at visit 2 and visit 7
The primary objective of this study is to evaluate the effect of the combination therapy on central and peripheral airway dimensions with CFD. The following primary outcome parameters will be determined: * Total airway resistance for the segmented airways * 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
4 secondary outcomes
Lung function tests: dynamic lung volumes, static lung volumes and airway resistances
Time frame: lung function tests will be perfomed at te following visits: screening, visit 1 (2 weeks after screening), visit 3 (6 weeks after screening), visit 5 (14 weeks after screening) and visit 7 (26 weeks after screening)
Subjective asthma control score
Time frame: Asthma Control Test (ACT) will be performed on visit 1, 2, 3, 5 and 7
Exhaled Nitric Oxide (NO)
Time frame: Exhaled NO will be measured on visit 2, 3, 5 and 7
Adverse events as a measure of safety
Time frame: Follow up of adverse events will be done during the entire study duration
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 10 Jul 2013.
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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, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inuvair in people with Asthma, run by Wilfried De Backer 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 5 inclusion and 14 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 10 Jul 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Differences in airway dimension (time frame: airway dimension will be measured at visit 2 and visit 7). 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 10 Jul 2013.