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

March 25, 2018 updated by: Jens Bräunlich, MD, University of Leipzig

Effect of Nasal Highflow in Combination With a Nebulizer on Reversibility in Lung Function in Patients With COPD

This study will prove to concept of effectiveness of NHF in combination with a nebulizer on reversibility of lung function in COPD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Department of Respiratory Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stable disease
  • COPD

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: inhalation with nebulizer
inhalation with an nebulizer via mouth
Device: Nebulizer
Inhalation will be done will Nebulizer and via mouth
ACTIVE_COMPARATOR: inhalation with nebulizer and NHF
inhalation with combination of nebulizer and nasal high flow (NHF) via nasal cavity
Device: Nasal high flow (NHF)
NHF will be combinated with a nebulizer. Inhalation will be done on nasal cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in forced expiratory volume in 1s (FEV1)
Time Frame: 45 minutes
litre
45 minutes
changes in breath way resistance (Rtot)
Time Frame: 45 min
45 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Study Director: Hubert Wirtz, MD, University of Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (ESTIMATE)

August 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 25, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 349-15-24082015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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