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Completed

NCT Number: NCT00743171

Long-Term Study On Home Spirometry After Lung Transplantation

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

Completed

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Graft loss

    Time frame: 3 year

Secondary outcomes

  1. BOS

    Time frame: 3 year

  2. Number of acute rejections

    Time frame: 3 year

  3. Number of hospitalizations

    Time frame: 3 year

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Aug 28, 2008
Registry last updated
Aug 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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