ClinicalTrials.gg
CompletedNCT03312673ASTADEMUpdated Oct 15, 2019

Asthma, Smoking, Emotional Deficits

An observational study in Asthma, Emotional Disorder and Alexithymia, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Asthma by Hospices Civils de Lyon — 3 open to participants now, 5 under way, none of them phase 3. Asthma · Hospices Civils de Lyon.

Started
2017
the only one that year
Observational
8 of 10
3 open now
Registered
3rd of 10
by date

Among the 10 studies in Asthma by Hospices Civils de Lyon, this one is the only one that started in 2017, is one of 8 observational ones, and was the 3rd registered.

Asthma

4,843 studies on the registry are indexed under Asthma; 602 are open to participants now.

Browse Asthma studies →

Open to participants now

3 of the 10 studies in Asthma by Hospices Civils de Lyon are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. The hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.

03

Conditions studied

  • Asthma
  • Emotional Disorder
  • Alexithymia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Asthma sufferers treated at the Croix Rousse hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women (> 18 years).
  • Asthma (mild, moderate, severe).
  • Beneficiary of social security

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Patients who oppose their participation in the study
  • Multiple drug users (psychoactive substances).
  • Patients with severe psychiatric antecedents and comorbidities.
  • Patients with cancer
  • Patients with cognitive impairment
  • Patients with speech, hearing, visual, and praxic disorders.
  • Any chronic and especially respiratory pathology other than asthma (, bronchiectasis), which can alter the study.
  • Patients not speaking French
  • Persons protected by law
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • Asthma population

    Patients (men and women) asthmatic smokers and non-smokers followed routinely in the pulmonology department, Croix-Rousse Hospital, Hospices Civils of Lyon.

    Other: Interview and tests of drawing.

Interventions

  • OtherInterview and tests of drawing.

    The intervention will take place with patients followed for asthma at the Croix Rousse hospital. Patients agreeing to participate in the study will come to the hospital for one hour and a half. They will answer questionnaires and tests of drawing. Results Restitution Session (optional) is proposed to patients within the next 4 weeks during a routine consultation.

06

What researchers measure

Primary outcomes

  1. Poor control of asthma

    The poor asthma control is defined by a score \<20 on the ACT test

    Time frame: During routine visit (one hour and a half)

  2. Emotional deficit such as alexithymia

    Defined by a score ≥ 44 points/100 on the Toronto scale

    Time frame: During routine visit (one hour and a half)

  3. Emotional deficit indicator traces

    Identifying indicator traces of emotional deficits according to the dimensions defining the alexithymia on the test of the tree and the drawing of the person

    Time frame: During routine visit (one hour and a half)

  4. Depression

    Defined by a score ≥ 11 points on the HADS scale

    Time frame: During routine visit (one hour and a half)

  5. Anxiety

    Defined by a score ≥ 11 points on the HADS scale

    Time frame: During routine visit (one hour and a half)

  6. Emotional valences

    Defined by 8 scores distinct on Diener's subjective well-being scale

    Time frame: During routine visit (one hour and a half)

07

Study locations

1 site
  • Service de Pneumologie Hôpital de la Croix-Rousse
    Lyon, 69004, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in May 2019, 17 months.

Of 364 non-industry observational studies under Asthma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 97. This study's 17 months is below that.

Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2017
First posted
Oct 18, 2017
StartActual
Nov 22, 2017
Primary completionActual
May 10, 2019
CompletionActual
May 10, 2019
Last update
Oct 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03312673
Responsible party
Sponsor
First posted
Oct 18, 2017
Start date
Nov 22, 2017
Primary completion
May 10, 2019
Completion
May 10, 2019
Last update
Oct 15, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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