NCT07050004

Brief Summary

Smoking is one of the main risk factors for chronic obstructive pulmonary disease (COPD), the primary indication for lung transplantation (LT) in France. Resumption of smoking after transplantation is associated with an increased risk of graft dysfunction, neoplasia and reduced survival. The prevalence of resumption of smoking after transplantation is based on few data available in the literature and is estimated at between 0 and 15%. The aim of this study is to determine the prevalence of smoking in transplantation. These results will enable healthcare professionalś to carry out information, education, prevention and support actions to help patients stop smoking throughout the transplantation process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,099

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 18, 2025

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessing the prevalence of active smoking in post-lung transplantation sing a questionnaire

    Proportion of transplant patients with active smoking

    one year post transplantation

Interventions

SMOKINGBEHAVIORAL

Patients who agree to take part in the study will complete a questionnaire covering the pre- and post-transplant aspects of smoking on their lifestyle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have benefited from a lung or cardiopulmonary transplantation

You may qualify if:

  • Patient who has undergone a lung transplant (single, double or heart-lung) and is being followed up in a transplant centre in France;
  • Age ≥ 18 years;
  • French-speaking patient;
  • Patient able to give his non-opposition.

You may not qualify if:

  • Patient under guardianship or curatorship;
  • Patient deprived of liberty ;
  • Patient under court protection;
  • Patients who object to the use of their data for this research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

MeSH Terms

Conditions

Tobacco Smoking

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2025

First Posted

July 3, 2025

Study Start

May 1, 2023

Primary Completion

July 11, 2024

Study Completion

December 11, 2024

Last Updated

July 3, 2025

Record last verified: 2025-06

Locations