Multidimensional Assessment of Dyspnea in Asthma

Asthma Clinical Trial

— MIDAS  

Official title:

Multidimensional Assessment of Dyspnea in Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04286906
• Other study ID #: 2019_11
• Secondary ID: 2019-A02795-52
• Status: Terminated
• Start date: May 18, 2020
• Est. completion date: August 11, 2022

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 133
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Dyspnea

Intervention

Other:
• Questionnaire
MultiDimensional Profile (MDP), Anxiety-Depression Hospital Scale (HADs), Nijmegen

Locations

Country	Name	City	State
France	Ch Dunkerque	Dunkerque
France	Hop Calmette Chu Lille	Lille
France	Hopital Saint Vincent - Saint Antoine - Lille	Lille
France	Hu Paris Nord Site Bichat Aphp - Paris 18	Paris
France	Hu Paris Sud Site Kremlin Bicetre Aphp - Le Kremlin Bicetre	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the sensory and affective dimensions of dyspnea	MultiDimensional Profile (MDP) scores QS and A2	At baseline
Secondary	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
Secondary	Association between dyspnea intensity and anxiety	Correlation between MDP scores QS and A2 and anxiety score HAD-A	At baseline
Secondary	Association between dyspnea intensity and hyperventilation	Correlation between MDP scores QS and A2 and the Nijmegen score	At baseline
Secondary	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
Secondary	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
Secondary	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