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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04286906
Other study ID # 2019_11
Secondary ID 2019-A02795-52
Status Terminated
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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