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Long-Term Study On Home Spirometry After Lung Transplantation

Long-Term Study On Home Spirometry After Lung Transplantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00743171
Enrollment
152
Registered
2008-08-28
Start date
2000-01-31
Completion date
2007-12-31
Last updated
2008-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterans, Death, Lung Transplantation, Rejection

Keywords

Lung transplantation, Home spirometry, non-adherence, outcomes, bronchiolitis obliterans

Brief summary

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

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

Interventions

None listed

Sponsors

Hannover Medical School
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Graft loss3 year

Secondary

MeasureTime frame
BOS3 year
Number of acute rejections3 year
Number of hospitalizations3 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026