NCT04276116

Brief Summary

The experimental design is a cluster randomized trial in 2 parallel groups: an intervention group with assessment of the pulmonary age and a control group without. The population studied is patients aged 25 or more, smoking for more than a year, seen in general practice consultation, for any reason. The progress of the study will be composed of an inclusion visit (M0) with a pulmonary age estimation for the intervention group and an measurement of the exhaled carbon monoxide for both groups, then a follow-up visit 6 months after the inclusion (M6) with an exhaled carbon monoxide measure for both groups, and a phone call at 12 months (M12) with a quality of life survey for both groups. The primary outcome is the smoking cessation at 6 months, confirmed by the carbon monoxide exhaled, at a scheduled consultation with the General practitioner (GP).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Oct 2023Jun 2026

First Submitted

Initial submission to the registry

January 31, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
3.7 years until next milestone

Study Start

First participant enrolled

October 27, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

January 31, 2020

Last Update Submit

April 20, 2026

Conditions

Smoking Cessation

Keywords

smoking cessationgenerally practicepulmonary agemotivation

Outcome Measures

Primary Outcomes (1)

  • Rate of smoking cessation at 6 months

    assessed with carbon monoxide measure in exhaled air by ppm

    6 months

Secondary Outcomes (4)

  • Assessment of tobacco cessation persistence at 12 months

    12 months

  • Tobacco cessation rate at 12 months

    12 months

  • Tobacco cessation characteristic

    6 months -12 months

  • GP acceptability of the pulmonary age tool

    6 months

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care + communication of pulmonary age

EXPERIMENTAL
Behavioral: Pulmonary age

Interventions

Pulmonary ageBEHAVIORAL

Communication of pulmonary age

Usual care + communication of pulmonary age

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient 25 years of age or older
  • Smoker for a year or more
  • Patient giving informed and written consent to participate in the study
  • Patient affiliated to a social security scheme

You may not qualify if:

  • Known respiratory illness, chronic or acute in progress or less than 3 weeks old (BPCO, asthma, other respiratory disease
  • Refusal
  • Myocardial infarction less than a year
  • Chest or abdominal pain preventing or limiting completion of the forced exhalation maneuver necessary for evaluation of "pulmonary age", whatever the cause
  • Oral or facial pain exacerbated by the mouthing of the mouthpiece
  • Stress urinary incontinence
  • Mental confusion or dementia
  • Pregnant or breastfeeding woman
  • Major protected
  • Do not understand french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Antoine

Paris, 75012, France

Location

Related Publications (4)

  • Parkes G, Greenhalgh T, Griffin M, Dent R. Effect on smoking quit rate of telling patients their lung age: the Step2quit randomised controlled trial. BMJ. 2008 Mar 15;336(7644):598-600. doi: 10.1136/bmj.39503.582396.25. Epub 2008 Mar 6.

    PMID: 18326503BACKGROUND

  • Lorenzo A, Noël F, Lorenzo M, Van Den Broucke J. Intérêt de la spirométrie en médecine générale pour la motivation au sevrage tabagique. Étude pilote de faisabilité et intérêt de l'" âge pulmonaire ".Rev Mal Respir. 13 févr 2017

    BACKGROUND

  • Kotz D, Wesseling G, Huibers MJ, van Schayck OC. Efficacy of confronting smokers with airflow limitation for smoking cessation. Eur Respir J. 2009 Apr;33(4):754-62. doi: 10.1183/09031936.00116308. Epub 2009 Jan 7.

    PMID: 19129277BACKGROUND

  • Morris JF, Temple W. Spirometric "lung age" estimation for motivating smoking cessation. Prev Med. 1985 Sep;14(5):655-62. doi: 10.1016/0091-7435(85)90085-4.

    PMID: 4070195BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Nicolas Roche, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 19, 2020

Study Start

October 27, 2023

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)