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Combination of NHF and Nebulizer on Lung Function in COPD (AEROFLOW)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nasal high flow (NHF)
Nebulizer
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring NHF, nasal highflow

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stable disease
  • COPD

Exclusion Criteria:

  • exacerbation
  • right heart decompensation
  • acute respiratory insufficiency
  • acute disease

Sites / Locations

  • Department of Respiratory Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

inhalation with nebulizer

inhalation with nebulizer and NHF

Arm Description

inhalation with an nebulizer via mouth

inhalation with combination of nebulizer and nasal high flow (NHF) via nasal cavity

Outcomes

Primary Outcome Measures

changes in forced expiratory volume in 1s (FEV1)
litre
changes in breath way resistance (Rtot)

Secondary Outcome Measures

Full Information

First Posted
August 22, 2016
Last Updated
March 25, 2018
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT02885103
Brief Title
Combination of NHF and Nebulizer on Lung Function in COPD
Acronym
AEROFLOW
Official Title
Effect of Nasal Highflow in Combination With a Nebulizer on Reversibility in Lung Function in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will prove to concept of effectiveness of NHF in combination with a nebulizer on reversibility of lung function in COPD patients.
Detailed Description
Patients will inhale on day 1 with a nebulizer and on another day with combination of nebulizer an NHF in a randomised order.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
NHF, nasal highflow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inhalation with nebulizer
Arm Type
Placebo Comparator
Arm Description
inhalation with an nebulizer via mouth
Arm Title
inhalation with nebulizer and NHF
Arm Type
Active Comparator
Arm Description
inhalation with combination of nebulizer and nasal high flow (NHF) via nasal cavity
Intervention Type
Device
Intervention Name(s)
Nasal high flow (NHF)
Intervention Description
NHF will be combinated with a nebulizer. Inhalation will be done on nasal cavity.
Intervention Type
Device
Intervention Name(s)
Nebulizer
Intervention Description
Inhalation will be done will Nebulizer and via mouth
Primary Outcome Measure Information:
Title
changes in forced expiratory volume in 1s (FEV1)
Description
litre
Time Frame
45 minutes
Title
changes in breath way resistance (Rtot)
Time Frame
45 min

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stable disease COPD Exclusion Criteria: exacerbation right heart decompensation acute respiratory insufficiency acute disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert Wirtz, MD
Organizational Affiliation
University of Leipzig
Official's Role
Study Director
Facility Information:
Facility Name
Department of Respiratory Medicine
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29261402
Citation
Braunlich J, Wirtz H. Oral Versus Nasal High-Flow Bronchodilator Inhalation in Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2018 Aug;31(4):248-254. doi: 10.1089/jamp.2017.1432. Epub 2017 Dec 20.
Results Reference
derived

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Combination of NHF and Nebulizer on Lung Function in COPD

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