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CompletedNCT01194596ESPITAPUpdated Feb 27, 2023

Effectiveness of Smoking Cessation Advice Combined With Spirometric Results in Adult Smokers (ESPITAP)

An interventional study of Smoking cessation advice and Spirometry and smoking cessation advice in Smoking Cessation, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Completed at 1 site in Spain. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
596
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effectiveness of the spirometric results information advice about the smoking habit the investigators designed an intervention trial in primary care.

Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction and abandonment than just smoking cessation advice.

Expected results: In adult smokers, a detailed discussion of the results yielded by spirometry tests together with brief smoking cessation advice on the part of the primary care practitioner can facilitate tobacco reduction and abandonment.

Read the detailed description

Main objective: To evaluate the effectiveness of smoking cessation advice combined with a detailed discussion of the spirometric results with the primary care practitioner on the smoking habit in adult smokers.

Methodology:

Design: Intervention study using a randomised control group. Setting: 12 primary care centres of two health areas. Participants: 600 smokers, aged 35 to 70 years, seeking medical advice from their primary care practitioner (GP) for any given reason (selection visit), excluding those patients with Chronic Obstructive Pulmonary Disease (COPD).

Measurements and interventions: In the selection visit, all participants will be required to undergo a series of tests that will include spirometry, tobacco dependence test, a test to measure the motivation to stop smoking and a structured questionnaire on sociodemographic data, smoking habit, respiratory symptomatology, etc. Based on the spirometric results, patients presenting airflow limitation will be excluded.

Randomisation will be performed using a computer programme. Randomisation will be carried out by the Coordinating Centre.

All other patients will be scheduled for another visit with their primary care practitioner one month later. In this visit (visit 1) and depending on the randomisation into 2 groups, one group will be given brief but structured smoking cessation advice together with a detailed and structured discussion of the spirometric results while the second group will also be given the same brief smoking cessation advice but without discussing the spirometric results. Both groups will be scheduled for a visit at 6 months (visit 2), and at 1 year (visit 3). During visit 2, the patient will be asked about his or her smoking habit. One month before visit 3, patients will be required to undergo again the series of tests performed prior to visit 1. In visit 3, all those patients who claim to have stopped smoking will be required to take a carbon monoxide test.

02

Conditions studied

  • Smoking Cessation

Keywords

  • smoking cessation advice
  • spirometry
  • primary health care
03

In context

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.

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

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult smoker subjects aged between 35 and 70 years

Exclusion criteria

Exclusion Criteria:

  • Previous antecedents of any respiratory disease
  • Suffering of any chronic or terminal disorder
  • Counterindication to undertake spirometry or that may hinder the performance of the spirometry test
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
596 participants (actual)

Study arms

  • Experimental
    Spirometry and lifestyle counseling

    Intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured discussion of the spirometric results.

    Behavioral: Smoking cessation advice · Behavioral: Spirometry and smoking cessation advice

  • No intervention
    Lifestyle counseling

    No intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine).

Interventions

  • BehavioralSmoking cessation advice

    Brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine), will be given in both arms.

    Also known as: Usual care, Intervention arm, No Intervention arm

  • BehavioralSpirometry and smoking cessation advice

    Intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured discussion of the spirometric results.

    Also known as: Intervention arm

06

What researchers measure

Primary outcomes

  1. smoking abstinence: self reported abstinence (12 or more months)

    smoking abstinence confirmed by an expired air carbon monoxide

    Time frame: 12 months

Secondary outcomes

  1. smoking reduction: self reported reduction

    smoking reduction by self reported reduction

    Time frame: 12 months

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Study locations

1 site
  • Jordi Gol i Gurina Foundation
    Barcelona, 08007, Spain
08

References and documents

Publications

  • Martin-Lujan F, Basora-Gallisa J, Villalobos F, Martin-Vergara N, Aparicio-Llopis E, Pascual-Palacios I, Santigosa-Ayala A, Catalin RE, Rey-Renones C, Sola R; ESPITAP Study Group Investigators. Effectiveness of a motivational intervention based on spirometry results to achieve smoking cessation in primary healthcare patients: randomised, parallel, controlled multicentre study. J Epidemiol Community Health. 2021 Oct;75(10):1001-1009. doi: 10.1136/jech-2020-216219. Epub 2021 Apr 21. PubMed 33883199 ↗
  • Sorli-Aguilar M, Martin-Lujan F, Flores-Mateo G, Jardi-Pinana C, Aparicio-Llopis E, Basora-Gallisa J, Sola-Alberich R; ESPITAP Study Group investigators. Adiposity markers and lung function in smokers: a cross-sectional study in a Mediterranean population. BMC Pulm Med. 2016 Dec 9;16(1):178. doi: 10.1186/s12890-016-0341-y. PubMed 27938399 ↗
  • Martin-Lujan F, Pinol-Moreso JL, Martin-Vergara N, Basora-Gallisa J, Pascual-Palacios I, Sagarra-Alamo R, Llopis EA, Basora-Gallisa MT, Pedret-Llaberia R; ESPITAP Study Group investigators. Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study. BMC Public Health. 2011 Nov 11;11:859. doi: 10.1186/1471-2458-11-859. PubMed 22078490 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2023, 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
NCT01194596
Lead sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Catalan Institute of Health
Responsible party
Sponsor
First posted
Sep 3, 2010
Start date
Jun 2008
Primary completion
Jun 2010
Completion
Jul 2011
Last update
Feb 27, 2023

Study contacts

Francisco Martín-Luján, MD
principal investigator · Catalan Institute of Health
Josep L Piñol-Moreso, PhD
study director · Catalan Institute of Health
Josep Basora-Gallisà, MD
study chair · Catalan Institute of Health

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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