NCT02885103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

August 22, 2016

Last Update Submit

March 25, 2018

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

NHFnasal highflow

Outcome Measures

Primary Outcomes (2)

  • changes in forced expiratory volume in 1s (FEV1)

    litre

    45 minutes

  • changes in breath way resistance (Rtot)

    45 min

Study Arms (2)

inhalation with nebulizer

PLACEBO COMPARATOR

inhalation with an nebulizer via mouth

Device: Nebulizer

inhalation with nebulizer and NHF

ACTIVE COMPARATOR

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

Device: Nasal high flow (NHF)

Interventions

Nasal high flow (NHF)DEVICE

NHF will be combinated with a nebulizer. Inhalation will be done on nasal cavity.

inhalation with nebulizer and NHF
NebulizerDEVICE

Inhalation will be done will Nebulizer and via mouth

inhalation with nebulizer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • stable disease
  • COPD

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Respiratory Medicine

Leipzig, Saxony, 04103, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29261402DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Hubert Wirtz, MD

    University of Leipzig

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 31, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

DE(1)