Multidimensional Assessment of Dyspnea in Asthma (MIDAS)

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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Asthmatic patients reporting breathlessness

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
One group (cohort); Asthmatic patients	Other: Questionnaire; MultiDimensional Profile (MDP), Anxiety-Depression Hospital Scale (HADs), Nijmegen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the sensory and affective dimensions of dyspnea	MultiDimensional Profile (MDP) scores QS and A2	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline
Association between dyspnea intensity and anxiety	Correlation between MDP scores QS and A2 and anxiety score HAD-A	At baseline
Association between dyspnea intensity and hyperventilation	Correlation between MDP scores QS and A2 and the Nijmegen score	At baseline
Association between change in dyspnea intensity and in asthma control	Correlation between change in MDP scores QS and A2 and change in ACQ-5	Difference between baseline and 6 months
Association between change in dyspnea intensity and in anxiety	Correlation between change in MDP scores QS and A2 and change in HAD-A score	Difference between baseline and 6 months
Association between change in dyspnea intensity and in hyperventilation	Correlation between change in MDP scores QS and A2 and change in the Nijmegen score	Difference between baseline and 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Cécile Chenivesse, MD PhD, CHU Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Breathlessness
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Dyspnea
• Other Study ID Numbers: 2019_11; 2019-A02795-52 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No