Multidimensional Assessment of Dyspnea in Asthma

NCT ID: NCT04286906

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 133 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-18
• Study Completion Date: 2022-08-11

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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

One group (cohort)

Asthmatic patients

Questionnaire

Intervention Type: OTHER

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

Interventions

Questionnaire

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cécile Chenivesse, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Lille

Locations

Ch Dunkerque

Dunkirk, , France

Hopital Saint Vincent - Saint Antoine - Lille

Lille, , 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

Countries

France

Other Identifiers

2019-A02795-52

Identifier Type: OTHER

Identifier Source: secondary_id

2019_11

Identifier Type: -

Identifier Source: org_study_id