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Long-Term Study On Home Spirometry After Lung Transplantation

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ClinicalTrials.gov Identifier: NCT00743171
Recruitment Status : Completed
First Posted : August 28, 2008
Last Update Posted : August 29, 2008
Sponsor:
Information provided by:
Hannover Medical School

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

Condition or disease
Lung Transplantation Rejection Death Bronchiolitis Obliterans

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


Study Type : Observational
Actual Enrollment : 152 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long-Term Study On Home Spirometry After Lung Transplantation
Study Start Date : January 2000
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. Graft loss [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. BOS [ Time Frame: 3 year ]
  2. Number of acute rejections [ Time Frame: 3 year ]
  3. Number of hospitalizations [ Time Frame: 3 year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Jens Gottlieb, Hannover Medical School, Dpt. Pneumology
ClinicalTrials.gov Identifier: NCT00743171     History of Changes
Other Study ID Numbers: MHH 2008-3
First Posted: August 28, 2008    Key Record Dates
Last Update Posted: August 29, 2008
Last Verified: August 2008

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

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