Clinical trial NCT04286906: Multidimensional Assessment of Dyspnea in Asthma
Official title: Multidimensional Assessment of Dyspnea in Asthma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Keywords: Asthma
Breathlessness
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asthmatic patients reporting 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.


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

Primary outcomes:
measure: Description of the sensory and affective dimensions of dyspnea
timeFrame: At baseline
Secondary outcomes:
measure: Association between dyspnea intensity and asthma control
timeFrame: At baseline
measure: Association between dyspnea intensity and anxiety
timeFrame: At baseline
measure: Association between dyspnea intensity and hyperventilation
timeFrame: At baseline
measure: Association between change in dyspnea intensity and in asthma control
timeFrame: Difference between baseline and 6 months
measure: Association between change in dyspnea intensity and in anxiety
timeFrame: Difference between baseline and 6 months
measure: Association between change in dyspnea intensity and in hyperventilation
timeFrame: Difference between baseline and 6 months
Other outcomes:
Locations:
city: Dunkerque
country: France
facility: Ch Dunkerque
city: Lille
country: France
facility: Hopital Saint Vincent - Saint Antoine - Lille
city: Lille
country: France
facility: Hop Calmette Chu Lille
city: Paris
country: France
facility: Hu Paris Nord Site Bichat Aphp - Paris 18
city: Paris
country: France
facility: Hu Paris Sud Site Kremlin Bicetre Aphp - Le Kremlin Bicetre
Study officials:
affiliation: CHU Lille
name: Cécile Chenivesse, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: