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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02936817
• Date of registration: 13/10/2016
• Prospective Registration: Yes
• Primary sponsor: FLUIDDA nv
• Public title: Study to Assess the Effect of the Aerobika Device in Addition to Standard of Care Treatment in Sputum Producing COPD Patients Using FRI
• Scientific 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)
• Date of first enrolment: December 2016
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02936817
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium

Contacts

• Name: Wilfried De Backer, MD, PhD
• Affiliation: University Hospital of Antwerp

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female subject = 40 and = 85 years old.

2. Written informed consent obtained.

3. Subject with a documented diagnosis of COPD with GOLD II to IV severity according to
the GOLD guidelines,

4. Subject with a cooperative attitude and ability to be trained to correctly use the
Aerobika® device.

5. 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.

6. 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.

7. Subject must be able to understand and complete the protocol requirements,
instructions and protocol-stated restrictions.

8. 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.

9. Subject should have unchanged smoking status within 3 months of Visit 1 and throughout
the study period.

Exclusion Criteria:

1. Pregnant or lactating female.

2. Subject with upper or lower airway infection that has not resolved within 4 weeks of
the Screening Visit.

3. 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.

4. Subjects unable to tolerate the increased work of breathing.

5. Subject with a history of cerebrovascular disease

6. Patient with clinical significant hemodynamic instability (i.e. blood pressure
instability).

7. Subject with recent facial, oral, or skull surgery or trauma.

8. Subject with active acute sinusitis.

9. Subject with active epistaxis (i.e. bleeding nose).

10. Subject with a history of esophageal surgery.

11. Subject with an active diagnosis of nausea on Visit 1.

12. Subject with active hemoptysis (i.e. bleeding from lungs).

13. Subject with untreated pneumothorax (i.e. untreated collapsed lung).

14. Subject with known or suspected tympanic membrane rupture or other middle ear
pathology.

15. Subject unable to perform pulmonary function testing.

16. 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.

17. Subject with active cancer or any other chronic disease with poor prognosis and /or
affecting patient status

18. Subject unlikely to comply with the protocol or unable to understand the nature,
scope, and possible consequences of the study.

19. 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).

20. Subject with a history of alcohol or substance abuse that, in the opinion of the
investigator, may be of clinical significance.

21. 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.

22. Subject with diagnosis of asthma.

23. Inability to correctly use the sham device.



Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

COPD

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Device: Aerobika® Device

Radiation: HRCT scans

Primary Outcome(s)

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]

Secondary Outcome(s)

Changes in Airway Wall Thickness (iVaww) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Forced Expiratory Flow between 25% to 75% of FVC (FEF 25-75) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Forced Expiratory Volume in 1 Second (FEV1) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Forced Vital Capacity (FVC) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Air Trapping [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Blood Vessel Density (iVbv) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Specific airway conductance (sGaw) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Tiffeneau Index (FEV1/FVC ratio) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Peak Expiratory Flow (PEF) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Distal airway resistance (iRaw) [Time Frame: At visit 1 and after 15 +/- 3 days of treatment]

Changes in Lung and Lobe Volumes (iVlobes) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Inspiratory Capacity (IC) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Airway Resistance (Raw) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Functional Residual Capacity (FRC) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Distal airway volumes (iVaw) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Changes in Total Lung Capacity (TLC) [Time Frame: At day 1 and after 15 +/- 3 days of treatment]

Secondary ID(s)

FLUI-2016-166

Source(s) of Monetary Support

Please refer to primary and secondary sponsors