Long-Term Study On Home Spirometry After Lung Transplantation - Full Text View

Sponsored by:	Hannover Medical School
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00743171

Purpose

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

Condition
Lung Transplantation Rejection Death Bronchiolitis Obliterans

MedlinePlus related topics: Lung Transplantation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Long-Term Study On Home Spirometry After Lung Transplantation

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:

Graft loss [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BOS [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Number of acute rejections [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Number of hospitalizations [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	152
Study Start Date:	January 2000
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

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.

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.

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.

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.

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.

Responsible Party:	Hannover Medical School, Dpt. Pneumology ( Jens Gottlieb )
Study ID Numbers:	MHH 2008-3
Study First Received:	August 26, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00743171
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:

Lung transplantation
Home spirometry
non-adherence
outcomes
bronchiolitis obliterans

Study placed in the following topic categories:

Lung Diseases, Interstitial
Lung Diseases, Obstructive
Death
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Bronchiolitis
Bronchitis
Bronchiolitis Obliterans

Additional relevant MeSH terms:

Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009