Long-Term Study On Home Spirometry After Lung Transplantation

Death Clinical Trial

Official title:

Long-Term Study On Home Spirometry After Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743171
• Other study ID #: MHH 2008-3
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: August 27, 2008
• Start date: January 2000
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Death
• Lung Transplantation
• Rejection

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Bjørtuft O, Johansen B, Boe J, Foerster A, Holter E, Geiran O. Daily home spirometry facilitates early detection of rejection in single lung transplant recipients with emphysema. Eur Respir J. 1993 May;6(5):705-8. — View Citation

De Geest S, Dobbels F, Fluri C, Paris W, Troosters T. Adherence to the therapeutic regimen in heart, lung, and heart-lung transplant recipients. J Cardiovasc Nurs. 2005 Sep-Oct;20(5 Suppl):S88-98. Review. — View Citation

Dew MA, Dimartini AF, De Vito Dabbs A, Zomak R, De Geest S, Dobbels F, Myaskovsky L, Switzer GE, Unruh M, Steel JL, Kormos RL, McCurry KR. Adherence to the medical regimen during the first two years after lung transplantation. Transplantation. 2008 Jan 27;85(2):193-202. doi: 10.1097/TP.0b013e318160135f. — View Citation

Finkelstein SM, Scudiero A, Lindgren B, Snyder M, Hertz MI. Decision support for the triage of lung transplant recipients on the basis of home-monitoring spirometry and symptom reporting. Heart Lung. 2005 May-Jun;34(3):201-8. — View Citation

Finkelstein SM, Snyder M, Edin-Stibbe C, Chlan L, Prasad B, Dutta P, Lindgren B, Wielinski C, Hertz MI. Monitoring progress after lung transplantation from home-patient adherence. J Med Eng Technol. 1996 Nov-Dec;20(6):203-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft loss		3 year	No
Secondary	BOS		3 year	No
Secondary	Number of acute rejections		3 year	No
Secondary	Number of hospitalizations		3 year	No