Long-Term Study On Home Spirometry After Lung Transplantation

This study has been completed.
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00743171
First received: August 26, 2008
Last updated: August 27, 2008
Last verified: August 2008
  Purpose

Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung function) of lung transplant recipients


Condition
Lung Transplantation
Rejection
Death
Bronchiolitis Obliterans

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long-Term Study On Home Spirometry After Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Graft loss [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BOS [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  • Number of acute rejections [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  • Number of hospitalizations [ Time Frame: 3 year ] [ Designated as safety issue: No ]

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
1
Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months
2
Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months
3
Non-adherent patient: patient performed < 50% of predicted HS within 24 months.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

lung transplant recipients surviving to outpatient follow-up >6 months in Hannover Medical School

Criteria

Inclusion Criteria:

  • Any type of lung transplant incl single, double, combined and re-do
  • > 18 years of age
  • LTx or HLTx ≥ 6mts post Tx
  • Stable health condition at study entry (pt stays within home environment)
  • Sufficient language skills for AMOS training
  • Successful AMOS training
  • Follow-up at our center (≥6 mts post LTx)
  • Willingness to participate by informed consent

Exclusion Criteria:

  • Refused consent
  • BOS diagnosis before study inclusion
  • Malignancy before study inclusion
  • Loss for follow-up (≤ 6 mts after study inclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743171

Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Jens T Gottlieb, MD Dpt. Pneumology
Principal Investigator: Christiane Kugler, MSc Dpt. Cardiothoracic, Transplantation and Vascular Surgery
  More Information

Publications:
Responsible Party: Jens Gottlieb, Hannover Medical School, Dpt. Pneumology
ClinicalTrials.gov Identifier: NCT00743171     History of Changes
Other Study ID Numbers: MHH 2008-3
Study First Received: August 26, 2008
Last Updated: August 27, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Lung transplantation
Home spirometry
non-adherence
outcomes
bronchiolitis obliterans

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 20, 2014