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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; COPD
• Intervention / Treatment: Device: Aerobika® Device; Radiation: HRCT scans

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital of Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Aerobika® device; For 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.

Device: Aerobika® Device; 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).; Other Names: Aerobika® Oscillating Positive Expiratory Pressure Therapy System; Radiation: HRCT 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.; Other Names: High Resolution Computed Tomography scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At day 1 and after 15 +/- 3 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Distal airway volumes (iVaw)	FRI parameters: HRCT scan will be taken at visit 1 and visit 3.	At day 1 and after 15 +/- 3 days of treatment
Changes in Distal airway resistance (iRaw)	FRI parameters: HRCT scan will be taken at visit 1 and visit 3.	At visit 1 and after 15 +/- 3 days of treatment
Changes in Lung and Lobe Volumes (iVlobes)	FRI parameters: HRCT scan will be taken at visit 1 and visit 3.	At day 1 and after 15 +/- 3 days of treatment
Changes in Airway Wall Thickness (iVaww)	FRI parameters: HRCT scan will be taken at visit 1 and visit 3.	At day 1 and after 15 +/- 3 days of treatment
Changes in Blood Vessel Density (iVbv)	FRI parameters: HRCT scan will be taken at visit 1 and visit 3.	At day 1 and after 15 +/- 3 days of treatment
Changes in Air Trapping	FRI parameters: HRCT scan will be taken at visit 1 and visit 3.	At day 1 and after 15 +/- 3 days of treatment
Changes in Forced Expiratory Volume in 1 Second (FEV1)	Spirometry parameter	At day 1 and after 15 +/- 3 days of treatment
Changes in Forced Vital Capacity (FVC)	Spirometry parameter	At day 1 and after 15 +/- 3 days of treatment
Changes in Peak Expiratory Flow (PEF)	Spirometry parameter	At day 1 and after 15 +/- 3 days of treatment
Changes in Forced Expiratory Flow between 25% to 75% of FVC (FEF 25-75)	Spirometry parameter	At day 1 and after 15 +/- 3 days of treatment
Changes in Inspiratory Capacity (IC)	Spirometry parameter	At day 1 and after 15 +/- 3 days of treatment
Changes in Tiffeneau Index (FEV1/FVC ratio)	Spirometry parameter	At day 1 and after 15 +/- 3 days of treatment
Changes in Functional Residual Capacity (FRC)	Body plethysmography parameter	At day 1 and after 15 +/- 3 days of treatment
Changes in Total Lung Capacity (TLC)	Body plethysmography parameter	At day 1 and after 15 +/- 3 days of treatment
Changes in Airway Resistance (Raw)	Body plethysmography parameters: Airway resistance	At day 1 and after 15 +/- 3 days of treatment
Changes in Specific airway conductance (sGaw)	Body plethysmography parameters: Airway resistance	At day 1 and after 15 +/- 3 days of treatment

Collaborators and Investigators

• Sponsor: FLUIDDA nv
• Investigators: Principal Investigator: Wilfried De Backer, MD, PhD, University Hospital of Antwerp

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Computed Tomography; CT scan; HRCT; High Resolution Computed Tomography scans; Functional Respiratory Imaging; sputum producing COPD patients; Aerobika® device
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: FLUI-2016-166