Pulmonary Disease, Chronic ObstructivePhase 2NCT02451540

Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging

A Phase 2 study testing HRCT scan and Roflumilast in people with Pulmonary Disease, Chronic Obstructive, run by FLUIDDA nv at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging. In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who… 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?: HRCT scan and Roflumilast
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteBelgium
Study dates: Sep 2015to 31 Aug 2017
Phase: Phase 2
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
Written informed consent obtained
Patient with Body mass index (BMI) ≥ 20
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
COPD patient with GOLD stages C and D
Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation

Show all 9Show fewer

Patient with smoking history of at least 10 pack-years
Patient takes a combination therapy of LABA/ LAMA 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 as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1
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.

Show all 10Show fewer

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 inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit
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

1 site in 1 country.

Belgium1 site

University Hospital of Antwerp
Edegem, Antwerp, 2650

Other trials in Belgium

About this study

Official title: Placebo Controlled Study to Assess the Effect of Roflumilast in Hyperinflated COPD Patients in Addition to LABA/LAMA Therapy Using Functional Respiratory Imaging.

In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging.

In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4.

The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component.

Image 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: HRCT scan, Placebo of Roflumilast, Roflumilast
Keywords: Pulmonary Disease, Chronic Obstructive, dynamics hyperinflation, Computed Tomography scan, CT scan, Functional Respiratory Imaging, FRI, Roflumilast, PRO
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.

HRCT scanRadiation
HRCT scan of thorax, at baseline and after 3 months
Placebo of RoflumilastDrug
Also called Placebo
Placebo, once a day in the morning during 3 months
RoflumilastDrug
Also called Daxas
Roflumilast, once a day in the morning during 3 months

Study groups in NCT02451540
Study group	Role	What they receive
Roflumilast	Active comparator	Patient will take Roflumilast (500 micrograms) once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months of treatment Receives: Radiation: HRCT scan; Drug: Roflumilast
Placebo	Placebo comparator	Patient will take the Placebo of Roflumilast once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months. Receives: Radiation: HRCT scan; Drug: Placebo of Roflumilast

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Airway volume (iVaw)
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Measured: At baseline and after 3 months of treatment
Changes in Airway resistance (iRaw)
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Measured: At baseline and after 3 months of treatment
Changes in Lobe volumes (iVlobes)
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Measured: At baseline and after 3 months of treatment
Changes in Air trapping
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Measured: At baseline and after 3 months of treatment
Changes in Internal Lobar Airflow Distribution
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Measured: At baseline and after 3 months of treatment
Low Attenuation or Emphysema Score
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Measured: At baseline and after 3 months of treatment
Changes in Blood Vessel Density
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Measured: At baseline and after 3 months of treatment
Changes in Airway Wall Thickness
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Measured: 3 months
Aerosol deposition concentrations
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Measured: At baseline and after 3 months of treatment

Secondary outcomes (5)

Changes in Spirometry
Spirometry is a composite outcome measure consisting of the following parameters:
- FEV1
- Peak Expiratory Flow (PEF)
- Forced Vital Capacity (FVC)
- Maximum Expiratory Flow at 50% of FVC (MEF 50)
- Maximum Expiratory Flow at 25% of FVC (MEF 25)
Measured: At baseline and after 3 months of treatment
Changes in Body plethysmography
Body plethysmography is a composite outcome measure consisting of the following parameters:
- Residual Volume (RV)
- TLC
- FRC
- Airway resistance (Raw)
Measured: At baseline and after 3 months of treatment
Changes in Diffusion capacity
Diffusion capacity is a composite outcome measure consisting of the following parameters:
- carbon monoxide transfer factor (TCO)
- Alveolar volume (VA)
Measured: At baseline and after 3 months of treatment
Changes in 6MWT
Exercise capacity: distance walked in 6 minutes (m), oxygen saturation measurement will be performed during the test
Measured: At baseline and after 3 months of treatment
Changes in Patient Related Outcome (PRO)
Patient Related Outcome is a composite outcome measure consisting of the following questionnaires:
- Borg CR10 Scale: measure of the present dyspnea and leg fatigue before and after exercise
- COPD assessment test (CAT): measure of the impact of COPD on your life
- Saint George's Respiratory Questionnaire (SGRQ): measure health related quality of life and comfort
Measured: At baseline and after 3 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201531 Aug 2017

First posted22 May 2015 (estimated)
Study startSep 2015
Primary completion31 Aug 2017
Study completion31 Aug 2017

Why it stopped: No new investigational product can be delivered to the site.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02451540
Sponsor's protocol ID: FLUI-2014-134
Status last verified: Mar 2018
First submitted: 7 May 2015
Last updated: 21 Mar 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo Controlled Study to Assess the Effect of Roflumilast in Hyperinflated COPD Patients in Addition to LABA/LAMA Therapy Using Functional Respiratory Imaging.
ClinicalTrials.gov ID: NCT02451540
Acronym / sponsor ID: FLUI-2014-134
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive, dynamics hyperinflation, Computed Tomography scan, CT scan, Functional Respiratory Imaging, FRI, Roflumilast, PRO
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: No new investigational product can be delivered to the site.
Enrolment: 13 participants (actual)
Lead sponsor: FLUIDDA nvIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: 31 Aug 2017 (actual)
Study completion: 31 Aug 2017 (actual)
First posted: 22 May 2015 (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 efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging.

The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component.

Image 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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Roflumilast	Active comparator	Radiation: HRCT scan, Drug: RoflumilastPatient will take Roflumilast (500 micrograms) once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months of treatment
Placebo	Placebo comparator	Radiation: HRCT scan, Drug: Placebo of RoflumilastPatient will take the Placebo of Roflumilast once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months.

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
Written informed consent obtained
Patient with Body mass index (BMI) ≥ 20
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
COPD patient with GOLD stages C and D

Key exclusion criteria (10 listed)

Pregnant or lactating females
Patient with severe immunological diseases and/ or severe acute infectious diseases
Patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1
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
HRCT scanHRCT scan of thorax, at baseline and after 3 months	Radiation	Placebo, Roflumilast
Placebo of RoflumilastAlso: PlaceboPlacebo, once a day in the morning during 3 months	Drug	Placebo
RoflumilastAlso: DaxasRoflumilast, once a day in the morning during 3 months	Drug	Roflumilast

Primary outcome

Changes in Airway volume (iVaw)
Time frame: At baseline and after 3 months of treatment
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Airway resistance (iRaw)
Time frame: At baseline and after 3 months of treatment
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Lobe volumes (iVlobes)
Time frame: At baseline and after 3 months of treatment
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Air trapping
Time frame: At baseline and after 3 months of treatment
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Internal Lobar Airflow Distribution
Time frame: At baseline and after 3 months of treatment
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Low Attenuation or Emphysema Score
Time frame: At baseline and after 3 months of treatment
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Blood Vessel Density
Time frame: At baseline and after 3 months of treatment
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Airway Wall Thickness
Time frame: 3 months
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Aerosol deposition concentrations
Time frame: At baseline and after 3 months of treatment
By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.

5 secondary outcomes

Changes in Spirometry
Time frame: At baseline and after 3 months of treatment
Changes in Body plethysmography
Time frame: At baseline and after 3 months of treatment
Changes in Diffusion capacity
Time frame: At baseline and after 3 months of treatment
Changes in 6MWT
Time frame: At baseline and after 3 months of treatment
Changes in Patient Related Outcome (PRO)
Time frame: At baseline and after 3 months of treatment

Results and safety

The study was stopped early (reason given: No new investigational product can be delivered to the site.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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, M.D., M.S. 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 2 study testing HRCT scan and Roflumilast in people with Pulmonary Disease, Chronic Obstructive, run by FLUIDDA nv 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 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 21 Mar 2018. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: No new investigational product can be delivered to the site.). Results are not available in the source record.

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 volume (iVaw) (time frame: At baseline and after 3 months of treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02451540.

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 21 Mar 2018.