Lung TransplantationNCT00743171
Long-Term Study On Home Spirometry After Lung Transplantation
An observational study of Lung Transplantation and Rejection, run by Hannover Medical School at 1 site in Germany.
Trial summary
Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung function) of lung transplant recipients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplantation, Rejection, Death
- How many people
- 152 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2000to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lung transplant recipients surviving to outpatient follow-up >6 months in Hannover Medical School
Who may be able to join
- 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
Who cannot join
- Refused consent
- BOS diagnosis before study inclusion
- Malignancy before study inclusion
- Loss for follow-up (≤ 6 mts after study inclusion
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Lung Transplantation, Rejection, Death, Bronchiolitis Obliterans
- Keywords
- Lung transplantation, Home spirometry, non-adherence, outcomes, bronchiolitis obliterans
- Medical subject headings
- Rejection, Psychology, Death, Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft loss
Measured: 3 year
Secondary outcomes (3)
BOS
Measured: 3 year
Number of acute rejections
Measured: 3 year
Number of hospitalizations
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startJan 2000
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Jens T Gottlieb, MD, Principal investigator, Dpt. PneumologyChristiane Kugler, MSc, Principal investigator, Dpt. Cardiothoracic, Transplantation and Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743171
- Sponsor's protocol ID
- MHH 2008-3
- Status last verified
- Aug 2008
- First submitted
- 26 Aug 2008
- Last updated
- 29 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
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 16015225Dew 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 18212623De 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 16160588Finkelstein 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 9029392Bjortuft 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Study On Home Spirometry After Lung Transplantation
- ClinicalTrials.gov ID
- NCT00743171
- Acronym / sponsor ID
- MHH 2008-3
- Conditions
- Lung Transplantation, Rejection, Death, Bronchiolitis Obliterans
- Keywords
- Lung transplantation, Home spirometry, non-adherence, outcomes, bronchiolitis obliterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lung transplant recipients surviving to outpatient follow-up >6 months in Hannover Medical School
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Refused consent
- BOS diagnosis before study inclusion
- Malignancy before study inclusion
- Loss for follow-up (≤ 6 mts after study inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Graft loss
Time frame: 3 year
3 secondary outcomes
BOS
Time frame: 3 year
Number of acute rejections
Time frame: 3 year
Number of hospitalizations
Time frame: 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2008.
- Background: PubMed 16015225Finkelstein 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.
- Background: PubMed 18212623Dew 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.
- Background: PubMed 16160588De 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.
- Background: PubMed 9029392Finkelstein 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.
- Background: PubMed 8390943Bjortuft 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens T Gottlieb, MD principal investigator
Dpt. Pneumology
Christiane Kugler, MSc principal investigator
Dpt. Cardiothoracic, Transplantation and Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and Rejection, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft loss (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00743171, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2008.