Skip to content

Multidimensional Assessment of Dyspnea in Asthma

Multidimensional Assessment of Dyspnea in Asthma

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04286906
Acronym
MIDAS
Enrollment
133
Registered
2020-02-27
Start date
2020-05-18
Completion date
2022-08-11
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Breathlessness

Brief 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.

Interventions

OTHERQuestionnaire

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

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

Design outcomes

Primary

MeasureTime frameDescription
Description of the sensory and affective dimensions of dyspneaAt baselineMultiDimensional Profile (MDP) scores QS and A2

Secondary

MeasureTime frameDescription
Association between dyspnea intensity and anxietyAt baselineCorrelation between MDP scores QS and A2 and anxiety score HAD-A
Association between dyspnea intensity and hyperventilationAt baselineCorrelation between MDP scores QS and A2 and the Nijmegen score
Association between dyspnea intensity and asthma controlAt baselineCorrelation between MDP scores QS and A2 and ACQ-5 Correlation between MDP scores QS and A2 and ACQ-5
Association between change in dyspnea intensity and in anxietyDifference between baseline and 6 monthsCorrelation between change in MDP scores QS and A2 and change in HAD-A score
Association between change in dyspnea intensity and in hyperventilationDifference between baseline and 6 monthsCorrelation between change in MDP scores QS and A2 and change in the Nijmegen score
Association between change in dyspnea intensity and in asthma controlDifference between baseline and 6 monthsCorrelation between change in MDP scores QS and A2 and change in ACQ-5

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026