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Pulmonary Disease, Chronic ObstructivePhase 4NCT02936817

Study to Assess the Effect of the Aerobika Device in Addition to Standard of Care Treatment in Sputum Producing COPD Patients Using FRI

A Phase 4 study testing Aerobika® Device and HRCT scans in people with Pulmonary Disease, Chronic Obstructive and COPD, run by FLUIDDA nv at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary: The primary objective of this study is to evaluate the effect of the Aerobika® device on the aerosol deposition pattern of concomitant inhalation medication using FRI. Secondary: The secondary objective of this study is to evaluate the effect of the Aerobika® device on the airway volume (iVaw), lung and lobe… Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive, COPD
What is being tested?
Aerobika® Device and HRCT scans
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBelgium
Study dates
Dec 2016to Aug 2017
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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subject ≥ 40 and ≤ 85 years old.
  • Written informed consent obtained.
  • Subject with a documented diagnosis of COPD with GOLD II to IV severity according to the GOLD guidelines,
  • Subject with a cooperative attitude and ability to be trained to correctly use the Aerobika® device.
  • Female subject t of childbearing potential must 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.
  • Subject must be sputum producing and treated in accordance with the GOLD guidelines. Sputum producing subjects are defined as patients who report productive cough with sputum "several days a week" (>2 days a week) or "almost every day" in the month prior to the study.
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  • Subject must be able to understand and complete the protocol requirements, instructions and protocol-stated restrictions.
  • Subject must use standard of care treatment. The regime of standard of care treatment must be on a stable dose of medication at least 1 week before Visit 1.
  • Subject should have unchanged smoking status within 3 months of Visit 1 and throughout the study period.

Who cannot join

  • Pregnant or lactating female.
  • Subject with upper or lower airway infection that has not resolved within 4 weeks of the Screening Visit.
  • Subject experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations and necessitates the administration or doubling of systemic corticosteroid treatment within 4 weeks of the Screening Visit.
  • Subjects unable to tolerate the increased work of breathing.
  • Subject with a history of cerebrovascular disease
  • Patient with clinical significant hemodynamic instability (i.e. blood pressure instability).
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  • Subject with recent facial, oral, or skull surgery or trauma.
  • Subject with active acute sinusitis.
  • Subject with active epistaxis (i.e. bleeding nose).
  • Subject with a history of esophageal surgery.
  • Subject with an active diagnosis of nausea on Visit 1.
  • Subject with active hemoptysis (i.e. bleeding from lungs).
  • Subject with untreated pneumothorax (i.e. untreated collapsed lung).
  • Subject with known or suspected tympanic membrane rupture or other middle ear pathology.
  • Subject unable to perform pulmonary function testing.
  • Subject 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.
  • Subject with active cancer or any other chronic disease with poor prognosis and /or affecting patient status
  • Subject unlikely to comply with the protocol or unable to understand the nature, scope, and possible consequences of the study.
  • Subject who received any investigational new drug within 4 weeks of Visit 1 or twice the duration of the biological effect of any drug (whichever is longer).
  • Subject with a history of alcohol or substance abuse that, in the opinion of the investigator, may be of clinical significance.
  • Subject who has undergone major surgery within 12 weeks of Visit 1 or has planned to undergo a major surgery before the end of the study.
  • Subject with diagnosis of asthma.
  • Inability to correctly use the sham device.

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: A Study to Assess the Effect of the Aerobika® Device in Addition to Standard of Care Treatment in Sputum Producing COPD Patients Using Functional Respiratory Imaging (FRI)

Primary:

The primary objective of this study is to evaluate the effect of the Aerobika® device on the aerosol deposition pattern of concomitant inhalation medication using FRI.

Secondary:

The secondary objective of this study is to evaluate the effect of the Aerobika® device on the airway volume (iVaw), lung and lobe volume (iVlobes), airway resistance (iRaw), hyperinflation, airway wall thickness (iVaww), blood vessel density (iVbv), and air trapping using FRI.

Being tested
Aerobika® Device, HRCT scans
Keywords
HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, CT scan, Computed Tomography, COPD, sputum producing COPD patients, Aerobika® device
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.

  • Aerobika® DeviceDevice

    Also called Aerobika® Oscillating Positive Expiratory Pressure Therapy System

    For a period of 15 +/- 3 days subjects will use the Aerobika® device before administration of their stable standard of care treatment regimen (i.e. study patients should use the device before each inhalation medication administration, with a minimum use of the device of twice daily).

  • HRCT scansRadiation

    Also called High Resolution Computed Tomography scans

    A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, and visit 3. An upper airway (UA) scan will be taken on visit 1.

Study groups in NCT02936817
Study groupRoleWhat they receive
Aerobika® deviceOtherFor a period of 15 +/- 3 days all subjects will use the Aerobika® device before administration of their stable standard of care treatment regimen (i.e. study patients should use the device before each inhalation medication administration, with a minimum use of the device of twice daily). HRCT scans wil be taken at visit 1 and visit 3.
Receives: Device: Aerobika® Device; Radiation: HRCT scans

What is being measured

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

  1. Changes in the number of deposited particles of concomitant inhalation medication per pre-defined airway section

    FRI parameters: HRCT scan will be taken at visit 1 and visit 3.

    Measured: At day 1 and after 15 +/- 3 days of treatment

Secondary outcomes (16)

  1. Changes in Distal airway volumes (iVaw)

    FRI parameters: HRCT scan will be taken at visit 1 and visit 3.

    Measured: At day 1 and after 15 +/- 3 days of treatment

  2. Changes in Distal airway resistance (iRaw)

    FRI parameters: HRCT scan will be taken at visit 1 and visit 3.

    Measured: At visit 1 and after 15 +/- 3 days of treatment

  3. Changes in Lung and Lobe Volumes (iVlobes)

    FRI parameters: HRCT scan will be taken at visit 1 and visit 3.

    Measured: At day 1 and after 15 +/- 3 days of treatment

  4. Changes in Airway Wall Thickness (iVaww)

    FRI parameters: HRCT scan will be taken at visit 1 and visit 3.

    Measured: At day 1 and after 15 +/- 3 days of treatment

  5. Changes in Blood Vessel Density (iVbv)

    FRI parameters: HRCT scan will be taken at visit 1 and visit 3.

    Measured: At day 1 and after 15 +/- 3 days of treatment

  6. Changes in Air Trapping

    FRI parameters: HRCT scan will be taken at visit 1 and visit 3.

    Measured: At day 1 and after 15 +/- 3 days of treatment

  7. Changes in Forced Expiratory Volume in 1 Second (FEV1)

    Spirometry parameter

    Measured: At day 1 and after 15 +/- 3 days of treatment

  8. Changes in Forced Vital Capacity (FVC)

    Spirometry parameter

    Measured: At day 1 and after 15 +/- 3 days of treatment

  9. Changes in Peak Expiratory Flow (PEF)

    Spirometry parameter

    Measured: At day 1 and after 15 +/- 3 days of treatment

  10. Changes in Forced Expiratory Flow between 25% to 75% of FVC (FEF 25-75)

    Spirometry parameter

    Measured: At day 1 and after 15 +/- 3 days of treatment

  11. Changes in Inspiratory Capacity (IC)

    Spirometry parameter

    Measured: At day 1 and after 15 +/- 3 days of treatment

  12. Changes in Tiffeneau Index (FEV1/FVC ratio)

    Spirometry parameter

    Measured: At day 1 and after 15 +/- 3 days of treatment

  13. Changes in Functional Residual Capacity (FRC)

    Body plethysmography parameter

    Measured: At day 1 and after 15 +/- 3 days of treatment

  14. Changes in Total Lung Capacity (TLC)

    Body plethysmography parameter

    Measured: At day 1 and after 15 +/- 3 days of treatment

  15. Changes in Airway Resistance (Raw)

    Body plethysmography parameters: Airway resistance

    Measured: At day 1 and after 15 +/- 3 days of treatment

  16. Changes in Specific airway conductance (sGaw)

    Body plethysmography parameters: Airway resistance

    Measured: At day 1 and after 15 +/- 3 days of treatment

Timeline

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

  1. First posted18 Oct 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02936817
Sponsor's protocol ID
FLUI-2016-166
Status last verified
Oct 2017
First submitted
13 Oct 2016
Last updated
3 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aerobika® Device and HRCT scans in people with Pulmonary Disease, Chronic Obstructive and COPD, 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 23 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 Oct 2017. 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?

Changes in the number of deposited particles of concomitant inhalation medication per pre-defined airway section (time frame: At day 1 and after 15 +/- 3 days of treatment). 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 NCT02936817.

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 Oct 2017.

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