Pulmonary Disease, Chronic ObstructivePhase 4NCT01480661
Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients
A Phase 4 study testing Roflumilast and Functional Respiratory Imaging in people with Pulmonary Disease, Chronic Obstructive, run by FLUIDDA nv at 2 sites in Belgium.
Trial summary
In this study the possible changes in airway geometry and function induced by 6 month oral treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients will be examined. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Roflumilast and Functional Respiratory Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesBelgium
- Study dates
- Dec 2011to Apr 2013
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient ≥ 30 years old
- Patient with BMI ≥ 20
- Written informed consent obtained
- Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study.
- Patient should be treated according to GOLD guidelines
- COPD patient with GOLD stages III until IV
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- Patient with smoking history of at least 10 pack-years
- Patient takes Spiriva® and a fixed combination of inhaled steroids and long acting beta agonist (LABA) at least 6 weeks before visit 1
- Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.
Who cannot join
- Pregnant or lactating females
- Patient with severe immunological diseases and/ or severe acute infectious diseases.
- Patient with heart failure
- Patient with diagnosis of cancer (except basal cell carcinoma)
- Patient with a history of depression associated with suicidal ideation or behaviour
- Patient with moderate or severe hepatic impairment.
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- Patient with lactose intolerance
- Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer).
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
ZNA Middelheim
Antwerp, Antwerp, 2020
Antwerp University Hospital
Edegem, Antwerp, 2650
About this study
Official title: Analysis of Airway Responses in Severe COPD Patients to Daxas®, Using CT Based Functional Respiratory Imaging
In this study the possible changes in airway geometry and function induced by 6 month oral treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients will be examined. The study population consists of 40 severe COPD patients, global initiative for chronic obstructive lung disease (GOLD) stages III until IV.
Imaging parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Roflumilast, Placebo of Roflumilast, Functional Respiratory Imaging
- Keywords
- Pulmonary Disease, Chronic Obstructive, Computed Tomography scan, Functional Respiratory Imaging, Roflumilast, Health Related Quality of Life
- 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.
RoflumilastDrug
Also called Daxas®
Roflumilast 500 µg, once a day in the morning during 6 months
Placebo of RoflumilastDrug
Placebo 500 µg, once a day in the morning during 6 months
Functional Respiratory ImagingRadiation
CT scan of thorax, at baseline and after 6 months
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast | Active comparator | Not described Receives: Drug: Roflumilast; Radiation: Functional Respiratory Imaging |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo of Roflumilast; Radiation: Functional Respiratory Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in airway geometry and function using CT based functional respiratory imaging.
The primary objective of this study is to evaluate the possible use of CT based functional respiratory imaging (CT-FRI) on the phenotyping of severe COPD patients after a 6 month treatment with Daxas®.
Measured: At baseline and after 6 months of treatment
Secondary outcomes (2)
Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique)
Imaging parameters will be assessed and the correlation with lung function will be checked before and after treatment.
Measured: At baseline and after 6 months of treatment
Health related quality of life
Imaging parameters will be assessed and the correlation with health related quality of life will be checked before and after treatment.
Measured: At baseline and after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLUIDDA nv
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried De Backer, MD, PhD, Principal investigator, University Hospital, AntwerpLieven Bedert, MD, Principal investigator, ZNA Middelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480661
- Sponsor's protocol ID
- FLUI-2011-77
- Other IDs
- 2011-004271-36
- Status last verified
- Sep 2013
- First submitted
- 21 Nov 2011
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Airway Responses in Severe COPD Patients to Daxas®, Using CT Based Functional Respiratory Imaging
- ClinicalTrials.gov ID
- NCT01480661
- Acronym / sponsor ID
- FLUI-2011-77
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Computed Tomography scan, Functional Respiratory Imaging, Roflumilast, Health Related Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Nov 2011 (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.
In this study the possible changes in airway geometry and function induced by 6 month oral treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients will be examined. The study population consists of 40 severe COPD patients, global initiative for chronic obstructive lung disease (GOLD) stages III until IV.
Imaging parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast | Active comparator | Drug: Roflumilast, Radiation: Functional Respiratory Imaging |
| Placebo | Placebo comparator | Drug: Placebo of Roflumilast, Radiation: Functional Respiratory Imaging |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patient ≥ 30 years old
- Patient with BMI ≥ 20
- Written informed consent obtained
- Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study.
- Patient should be treated according to GOLD guidelines
Key exclusion criteria (9 listed)
- Pregnant or lactating females
- Patient with severe immunological diseases and/ or severe acute infectious diseases.
- Patient with heart failure
- Patient with diagnosis of cancer (except basal cell carcinoma)
- Patient with a history of depression associated with suicidal ideation or behaviour
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 |
|---|---|---|
| RoflumilastAlso: Daxas®Roflumilast 500 µg, once a day in the morning during 6 months | Drug | Roflumilast |
| Placebo of RoflumilastPlacebo 500 µg, once a day in the morning during 6 months | Drug | Placebo |
| Functional Respiratory ImagingCT scan of thorax, at baseline and after 6 months | Radiation | Placebo, Roflumilast |
Primary outcome
Changes in airway geometry and function using CT based functional respiratory imaging.
Time frame: At baseline and after 6 months of treatment
The primary objective of this study is to evaluate the possible use of CT based functional respiratory imaging (CT-FRI) on the phenotyping of severe COPD patients after a 6 month treatment with Daxas®.
2 secondary outcomes
Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique)
Time frame: At baseline and after 6 months of treatment
Health related quality of life
Time frame: At baseline and after 6 months of treatment
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 19 Sep 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 De Backer, MD, PhD principal investigator
University Hospital, Antwerp
Lieven Bedert, MD principal investigator
ZNA Middelheim
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roflumilast and Functional Respiratory Imaging in people with Pulmonary Disease, Chronic Obstructive, run by FLUIDDA nv at 2 sites 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 9 inclusion and 9 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 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Changes in airway geometry and function using CT based functional respiratory imaging. (time frame: At baseline and after 6 months of treatment). 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 19 Sep 2013.