Long-Term Study On Home Spirometry After Lung Transplantation

Hannover Medical School (MHH)

Status: Completed

Conditions: Bronchiolitis Obliterans; Death; Lung Transplantation; Rejection

Study type: Observational

Funder types: Other

Identifiers

NCT00743171

MHH 2008-3

Details and patient eligibility

About

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

Full 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

Enrollment: 152 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

152 participants in 3 patient groups

1

Description:

Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months

2

Description:

Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months

3

Description:

Non-adherent patient: patient performed \< 50% of predicted HS within 24 months.