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Ipilimumab-induced Lung Toxicity: Observational Study

NCT02755233 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2016-04-28

No results posted yet for this study

Summary

Serial spirometries and measurements of CO-diffusion capacity (DLCO) in patients with MM before and during treatment with ipilimumab are performed. A reduction from baseline of forced vital capacity (FVC) of ≥10%, or ≥15% of DLCO was defined clinically meaningful, thus indicative for pulmonary toxicity.

Conditions

Interventions

OTHER

Pulmonary Function

Spirometry and DLCO were measured according to performance standards based on the statements from the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Values of DLCO were adjusted for the patient's current hemoglobin value, and the patients were asked to withhold cigarette smoking at least four hours before pulmonary function testing. Lung volumes and DLCO were measured with a commercial ZAN300 CO Diffusion system (nSpire Health GmbH, Oberthulba, Germany)

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Daniel Franzen, MD · University Hospital Zurich, Divison of Pneumology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02755233 on ClinicalTrials.gov