NCT06179342

Brief Summary

Comparison of the new multiple-breath washout method (ndd Medizintechnik Zürich, Trueflow™/Truecheck™) with established methods of lung function diagnostics in patients with idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, asthma and cardiopulmonary healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

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

June 21, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2.7 years

First QC Date

December 6, 2023

Last Update Submit

May 6, 2024

Conditions

Pulmonary FibrosisCOPDAsthma

Outcome Measures

Primary Outcomes (1)

  • Lung Clearance Index

    comparison of the lung clearance index of the different patient groups

    immediately ofter the procedure

Study Arms (4)

Cardiopulmonary healthy

Patients in whom there is no evidence of cardiopulmonary dysfunction in the course of diagnostics

Diagnostic Test: Multiple-Breath-Washout

Idiopathic pulmonary fibrosis

idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines

Diagnostic Test: Multiple-Breath-Washout

Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) with/without emphysema

Diagnostic Test: Multiple-Breath-Washout

Asthma bronchiale

Diagnostic Test: Multiple-Breath-Washout

Interventions

Multiple-Breath-WashoutDIAGNOSTIC_TEST

One additional diagnostic test is performed using the Multiple-Breath-Washout technology

Asthma bronchialeCardiopulmonary healthyChronic obstructive pulmonary diseaseIdiopathic pulmonary fibrosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the study center with one of the above-mentioned diseases

You may qualify if:

  • Age ≥ 18 years
  • existing consent
  • confirmed diagnosis of one of the following diseases
  • idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines
  • chronic obstructive pulmonary disease (COPD) with/without emphysema
  • bronchial asthma
  • or patients who are admitted with suspected cardiopulmonary dysfunction (e.g. with unclear dyspnoea) and in whom there is no evidence of cardiopulmonary dysfunction during the diagnostic process (comparison group of "healthy" patients).
  • Indication for routine performance of the following pulmonary function tests during the current inpatient stay: Whole Body Plethysmography \& Diffusion Capacity of the Lung (single-breath)

You may not qualify if:

  • Age \< 18 years
  • Simultaneous presence of at least two of the following diseases (IPF, COPD/emphysema, asthma, pulmonary arterial hypertension)
  • any medical, psychological or other condition that restricts the patient's ability to give informed consent for voluntary participation in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wissenschaftliches Institut Bethanien e.V.

Solingen, North Rhine-Westphalia, 42699, Germany

Location

MeSH Terms

Conditions

Pulmonary FibrosisPulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseDisease AttributesBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lars Hagmeyer, PD Dr.

    Wissenschaftliches Institut Bethanien e.V

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 21, 2023

Study Start

June 21, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations

DE(1)