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Sponsored by: |
Hannover Medical School |
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Information provided by: | Hannover Medical School |
ClinicalTrials.gov Identifier: | NCT00743171 |
Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung function) of lung transplant recipients
Condition |
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Lung Transplantation Rejection Death Bronchiolitis Obliterans |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Long-Term Study On Home Spirometry After Lung Transplantation |
Enrollment: | 152 |
Study Start Date: | January 2000 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months
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2
Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months
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3
Non-adherent patient: patient performed < 50% of predicted HS within 24 months.
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Study period between 1/2/2000 and 31/12/2003 Follow-up until 31/12/2007
Patient will be stratified according to adherence to HS during the first 2 postoperative years Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months Non-adherent patient: patient performed < 50% of predicted HS within 24 months.
Primary outcome measure graft loss at end of follow-up
Secondary outcome measure number of acute rejections during follow-up number of hospitalisation during follow-up Incidence of bronchiolitis obliterans syndrome during follow-up
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
lung transplant recipients surviving to outpatient follow-up >6 months in Hannover Medical School
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Hannover Medical School | |
Hannover, Germany, 30625 |
Principal Investigator: | Jens T Gottlieb, MD | Dpt. Pneumology |
Principal Investigator: | Christiane Kugler, MSc | Dpt. Cardiothoracic, Transplantation and Vascular Surgery |
Responsible Party: | Hannover Medical School, Dpt. Pneumology ( Jens Gottlieb ) |
Study ID Numbers: | MHH 2008-3 |
Study First Received: | August 26, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00743171 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Lung transplantation Home spirometry non-adherence outcomes bronchiolitis obliterans |
Lung Diseases, Interstitial Lung Diseases, Obstructive Death Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Bronchiolitis Bronchitis Bronchiolitis Obliterans |
Bronchial Diseases |