Clinical trial NCT02936817: Study to Assess the Effect of the Aerobika Device in Addition to Standard of Care Treatment in Sputum Producing COPD Patients Using FRI
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
COPD
Keywords: HRCT
High Resolution Computed Tomography scans
Functional Respiratory Imaging
CT scan
Computed Tomography
COPD
sputum producing COPD patients
Aerobika® device
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 volume (iVlobes), airway resistance (iRaw), hyperinflation, airway wall thickness (iVaww), blood vessel density (iVbv), and air trapping using FRI.


Eligibility 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.

Primary outcomes:
measure: Changes in the number of deposited particles of concomitant inhalation medication per pre-defined airway section
timeFrame: At day 1 and after 15 +/- 3 days of treatment
Secondary outcomes:
measure: Changes in Distal airway volumes (iVaw)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Distal airway resistance (iRaw)
timeFrame: At visit 1 and after 15 +/- 3 days of treatment
measure: Changes in Lung and Lobe Volumes (iVlobes)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Airway Wall Thickness (iVaww)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Blood Vessel Density (iVbv)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Air Trapping
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Forced Vital Capacity (FVC)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Peak Expiratory Flow (PEF)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Forced Expiratory Flow between 25% to 75% of FVC (FEF 25-75)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Inspiratory Capacity (IC)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Tiffeneau Index (FEV1/FVC ratio)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Functional Residual Capacity (FRC)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Total Lung Capacity (TLC)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Airway Resistance (Raw)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
measure: Changes in Specific airway conductance (sGaw)
timeFrame: At day 1 and after 15 +/- 3 days of treatment
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital of Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital of Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: