Status:
TERMINATED
Multidimensional Assessment of Dyspnea in Asthma
Lead Sponsor:
University Hospital, Lille
Conditions:
Asthma
Eligibility:
All Genders
18+ years
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 particul...
Eligibility Criteria
Inclusion
- 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
- Experience of dyspnea in the past 7 days
- Age\> 18 years old
- Social protection affiliation 5. Written informed consent
Exclusion
- Age \<18 years old
- Active smoker or quitting smoking for less than a year
- 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).
- Inability to respond to questionnaires for any reason
- 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
- Pregnancy
- Persons under guardianship
- Refusal to sign consent or participate in the study
- No social protection affiliation
Key Trial Info
Start Date :
May 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 11 2022
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04286906
Start Date
May 18 2020
End Date
August 11 2022
Last Update
January 26 2023
Active Locations (5)
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1
Ch Dunkerque
Dunkirk, France
2
Hopital Saint Vincent - Saint Antoine - Lille
Lille, France, 59037
3
Hop Calmette Chu Lille
Lille, France
4
Hu Paris Nord Site Bichat Aphp - Paris 18
Paris, France