NCT02636452

Brief Summary

In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom. Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 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

October 31, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

3.9 years

First QC Date

November 9, 2015

Last Update Submit

October 26, 2018

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • Alveolar-arterial oxygen partial pressure difference (AaDO2) in cardipulmonary exercise testing in ILD

    quarterly, three years

Interventions

cardiopulmonary exercise testOTHER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with Interstitial lung diseases

You may qualify if:

  • informed consent provided
  • ILD

You may not qualify if:

  • no informed consent
  • no ILD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine

Solingen, North Rhine-Westphalia, 42699, Germany

Location

Related Publications (3)

  • Fischer A, West SG, Swigris JJ, Brown KK, du Bois RM. Connective tissue disease-associated interstitial lung disease: a call for clarification. Chest. 2010 Aug;138(2):251-6. doi: 10.1378/chest.10-0194.

    PMID: 20682528RESULT

  • Fell CD, Liu LX, Motika C, Kazerooni EA, Gross BH, Travis WD, Colby TV, Murray S, Toews GB, Martinez FJ, Flaherty KR. The prognostic value of cardiopulmonary exercise testing in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2009 Mar 1;179(5):402-7. doi: 10.1164/rccm.200802-241OC. Epub 2008 Dec 12.

    PMID: 19074597RESULT

  • Hagmeyer L, Herkenrath S, Anduleit N, Treml M, Randerath W. Cardiopulmonary Exercise Testing Allows Discrimination Between Idiopathic Non-specific Interstitial Pneumonia and Idiopathic Pulmonary Fibrosis in Mild to Moderate Stages of the Disease. Lung. 2019 Dec;197(6):721-726. doi: 10.1007/s00408-019-00282-9. Epub 2019 Nov 1.

    PMID: 31676976DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

November 9, 2015

First Posted

December 21, 2015

Study Start

October 31, 2013

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

DE(1)