Combination of NHF and Nebulizer on Lung Function in COPD

NCT ID: NCT02885103

Last Updated: 2018-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-11-30

Brief Summary

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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

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Patients will inhale on day 1 with a nebulizer and on another day with combination of nebulizer an NHF in a randomised order.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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inhalation with nebulizer

inhalation with an nebulizer via mouth

Group Type PLACEBO_COMPARATOR

Nebulizer

Intervention Type DEVICE

Inhalation will be done will Nebulizer and via mouth

inhalation with nebulizer and NHF

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

Group Type ACTIVE_COMPARATOR

Nasal high flow (NHF)

Intervention Type DEVICE

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

Interventions

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Nasal high flow (NHF)

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

Intervention Type DEVICE

Nebulizer

Inhalation will be done will Nebulizer and via mouth

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* stable disease
* COPD

Exclusion Criteria

* exacerbation
* right heart decompensation
* acute respiratory insufficiency
* acute disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Jens Bräunlich, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hubert Wirtz, MD

Role: STUDY_DIRECTOR

University of Leipzig

Locations

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Department of Respiratory Medicine

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29261402 (View on PubMed)

Other Identifiers

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349-15-24082015

Identifier Type: -

Identifier Source: org_study_id

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