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

NCT02936817 | Completed Phase 4

• 1 other identifier: FLUI-2016-166
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (16)

• Changes in Distal airway volumes (iVaw)

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

• Changes in Distal airway resistance (iRaw)

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

• Changes in Lung and Lobe Volumes (iVlobes)

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

• Changes in Airway Wall Thickness (iVaww)

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

• Changes in Blood Vessel Density (iVbv)

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

Study Arms (1)

Aerobika® device

OTHER

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; Radiation: HRCT scans

Interventions

Aerobika® Device 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).

Also known as: Aerobika® Oscillating Positive Expiratory Pressure Therapy System

Aerobika® device

HRCT scans RADIATION

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.

Also known as: High Resolution Computed Tomography scans

Aerobika® device

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• FLUIDDA nv: lead

Study Sites (1)

University Hospital of Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilfried De Backer, MD, PhD

  University Hospital of Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 18, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-10

Locations

BE (1)