CClinicalTrials.gg
TerminatedNCT04286906MIDASUpdated Jan 26, 2023

Multidimensional Assessment of Dyspnea in Asthma

An observational study in Asthma, sponsored by University Hospital, Lille. Terminated at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.

Sponsored by University Hospital, Lille · Observational

Why this study was terminated
greatly reduced active file of potentially includible patients
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
133
Ages
18 Years and older
Sex
All
01

Study summary

Breathlessness is a symptom of asthma that occurs in relation with lower airway obstruction. However, this sensation is not specific of asthma and may be the expression of other disorders. In particular, it can testify to anxiety or hyperventilation, two disorders frequently associated with asthma. The systematic interpretation of dyspnea as a manifestation of asthma in asthmatic patients may lead to an inappropriate increase in asthma controllers.

Identifying the cause of dyspnea in asthmatic patients (airway obstruction, anxiety or hyperventilation) is therefore crucial for the clinician.

This could be facilitated by a multidimensional assessment of dyspnea, evaluating the kind of sensation felt by the patient (for example chest tightness, air hunger etc.) and emotions associated to respiratory sensations (for example anxiety, fear etc.).

The objectives of this project are to assess: (1) the sensory and affective dimensions of dyspnea in asthma and, (2) their connection to asthma control, anxiety and depression.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Breathlessness
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 133 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Asthmatic patients reporting breathlessness

Inclusion criteria

  1. Diagnosis of asthma confirmed by:

    • A history of symptoms compatible with asthma
    • AND a history of airway obstruction, according to the GINA definition (2017): FEV1/FVC ratio lower than the lower limit of the predicted value at baseline or after a bronchial provocation test
    • AND a variability of airway obstruction defined by at least one of the following criteria:

    oReversibility of airway obstruction after bronchodilators (400 µg of salbutamol): FEV 1 increases by> 200 mL and> 12% compared to baseline

    • OR delta peak-flow over the day / average peak-flow averaged over 2 weeks> 10%
    • OR variability in FEV1 between two visits> 200 mL and> 12%
    • OR an increase in FEV1 of> 200 mL and> 12% compared to the baseline after 4 weeks of treatment with oral corticosteroids
    • OR a positive methacholine challenge: decrease in FEV1 by more than 20% for a dose \<1600 µg
  2. Experience of dyspnea in the past 7 days
  3. Age> 18 years old
  4. Social protection affiliation 5. Written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Age \<18 years old
  2. Active smoker or quitting smoking for less than a year
  3. Severe exacerbation or respiratory infection within 4 weeks before inclusion (severe exacerbation is defined by an increase in systemic corticosteroid therapy for at least 3 days or injection of a single dose of delayed corticosteroid, emergency room visit due to asthma (with systemic corticosteroid therapy), or hospitalization due to asthma).
  4. Inability to respond to questionnaires for any reason
  5. Presence of any pathology other than asthma which may be responsible for dyspnea, in particular cardiovascular or respiratory (ischemic heart disease, heart failure, chronic obstructive pulmonary disease, diffuse interstitial pneumonitis, lung cancer, non-exhaustive list) with the exception of anxiety and hyperventilation syndrome
  6. Pregnancy
  7. Persons under guardianship
  8. Refusal to sign consent or participate in the study
  9. No social protection affiliation
05

Study design

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

Groups and cohorts

  • One group (cohort)

    Asthmatic patients

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    MultiDimensional Profile (MDP), Anxiety-Depression Hospital Scale (HADs), Nijmegen

06

What researchers measure

Primary outcomes

  1. Description of the sensory and affective dimensions of dyspnea

    MultiDimensional Profile (MDP) scores QS and A2

    Time frame: At baseline

Secondary outcomes

  1. Association between dyspnea intensity and asthma control

    Correlation between MDP scores QS and A2 and ACQ-5 Correlation between MDP scores QS and A2 and ACQ-5

    Time frame: At baseline

  2. Association between dyspnea intensity and anxiety

    Correlation between MDP scores QS and A2 and anxiety score HAD-A

    Time frame: At baseline

  3. Association between dyspnea intensity and hyperventilation

    Correlation between MDP scores QS and A2 and the Nijmegen score

    Time frame: At baseline

  4. Association between change in dyspnea intensity and in asthma control

    Correlation between change in MDP scores QS and A2 and change in ACQ-5

    Time frame: Difference between baseline and 6 months

  5. Association between change in dyspnea intensity and in anxiety

    Correlation between change in MDP scores QS and A2 and change in HAD-A score

    Time frame: Difference between baseline and 6 months

  6. Association between change in dyspnea intensity and in hyperventilation

    Correlation between change in MDP scores QS and A2 and change in the Nijmegen score

    Time frame: Difference between baseline and 6 months

07

Study locations

5 sites
  • Ch Dunkerque
    Dunkerque, France
  • Hopital Saint Vincent - Saint Antoine - Lille
    Lille, 59037, France
  • Hop Calmette Chu Lille
    Lille, France
  • Hu Paris Nord Site Bichat Aphp - Paris 18
    Paris, France
  • Hu Paris Sud Site Kremlin Bicetre Aphp - Le Kremlin Bicetre
    Paris, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04286906
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Feb 27, 2020
Start date
May 18, 2020
Primary completion
Aug 11, 2022
Completion
Aug 11, 2022
Last update
Jan 26, 2023

Study contacts

Cécile Chenivesse, MD PhD
principal investigator · CHU Lille

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 terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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