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CompletedNCT00743171Updated Aug 29, 2008

Long-Term Study On Home Spirometry After Lung Transplantation

An observational study in Lung Transplantation, Rejection and Death, sponsored by Hannover Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-08-29.

Sponsored by Hannover Medical School · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
152
Ages
18 Years to 70 Years
Sex
All
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Study summary

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

Read the 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

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Conditions studied

  • Lung Transplantation
  • Rejection
  • Death
  • Bronchiolitis Obliterans

Keywords

  • Lung transplantation
  • Home spirometry
  • non-adherence
  • outcomes
  • bronchiolitis obliterans
03

In context

Bronchiolitis

360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.

This study's enrollment of 152 is below the median of 196 across 92 observational studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

lung transplant recipients surviving to outpatient follow-up >6 months in Hannover Medical School

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

Exclusion Criteria:

  • Refused consent
  • BOS diagnosis before study inclusion
  • Malignancy before study inclusion
  • Loss for follow-up (≤ 6 mts after study inclusion
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
152 participants (actual)

Groups and 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.

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What researchers measure

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

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Study locations

1 site
  • Hannover Medical School
    Hannover, 30625, Germany
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References and documents

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. doi: 10.1016/j.hrtlng.2004.09.003. PubMed 16015225 ↗
  • 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. PubMed 18212623 ↗
  • 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. doi: 10.1097/00005082-200509001-00010. PubMed 16160588 ↗
  • 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. doi: 10.3109/03091909609008999. PubMed 9029392 ↗
  • Bjortuft 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. PubMed 8390943 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00743171
Lead sponsor
Hannover Medical School
First posted
Aug 28, 2008
Start date
Jan 2000
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Aug 29, 2008

Study contacts

Jens T Gottlieb, MD
principal investigator · Dpt. Pneumology
Christiane Kugler, MSc
principal investigator · Dpt. Cardiothoracic, Transplantation and Vascular Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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