AsthmaMIDASNCT04286906
Multidimensional Assessment of Dyspnea in Asthma
An observational study of Asthma, run by University Hospital, Lille at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Questionnaire
- How many people
- 133 participants
- Where
- 5 sitesFrance
- Study dates
- 18 May 2020to 11 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Asthmatic patients reporting breathlessness
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- Persons under guardianship
- Refusal to sign consent or participate in the study
- No social protection affiliation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Ch Dunkerque
Dunkirk
Hopital Saint Vincent - Saint Antoine - Lille
Lille, 59037
Hop Calmette Chu Lille
Lille
Hu Paris Nord Site Bichat Aphp - Paris 18
Paris
Hu Paris Sud Site Kremlin Bicetre Aphp - Le Kremlin Bicetre
Paris
About this study
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.
Read more
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
- Being tested
- Questionnaire
- Keywords
- Asthma, Breathlessness
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
MultiDimensional Profile (MDP), Anxiety-Depression Hospital Scale (HADs), Nijmegen
| Study group | Role | What they receive |
|---|---|---|
| One group (cohort) | Asthmatic patients Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the sensory and affective dimensions of dyspnea
MultiDimensional Profile (MDP) scores QS and A2
Measured: At baseline
Secondary outcomes (6)
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
Measured: At baseline
Association between dyspnea intensity and anxiety
Correlation between MDP scores QS and A2 and anxiety score HAD-A
Measured: At baseline
Association between dyspnea intensity and hyperventilation
Correlation between MDP scores QS and A2 and the Nijmegen score
Measured: At baseline
Association between change in dyspnea intensity and in asthma control
Correlation between change in MDP scores QS and A2 and change in ACQ-5
Measured: Difference between baseline and 6 months
Association between change in dyspnea intensity and in anxiety
Correlation between change in MDP scores QS and A2 and change in HAD-A score
Measured: Difference between baseline and 6 months
Association between change in dyspnea intensity and in hyperventilation
Correlation between change in MDP scores QS and A2 and change in the Nijmegen score
Measured: Difference between baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start18 May 2020
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Why it stopped: greatly reduced active file of potentially includible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Chenivesse, MD PhD, Principal investigator, CHU Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286906
- Sponsor's protocol ID
- 2019_11
- Other IDs
- 2019-A02795-52
- Acronym
- MIDAS
- Status last verified
- Jan 2023
- First submitted
- 21 Feb 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Assessment of Dyspnea in Asthma
- ClinicalTrials.gov ID
- NCT04286906
- Acronym / sponsor ID
- MIDAS / 2019_11
- Conditions
- Asthma
- Keywords
- Asthma, Breathlessness
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: greatly reduced active file of potentially includible patients
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group (cohort) | – | Other: QuestionnaireAsthmatic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Asthmatic patients reporting breathlessness
Key inclusion criteria (12 listed)
- Diagnosis of asthma confirmed by:
- oReversibility of airway obstruction after bronchodilators (400 µg of salbutamol): FEV 1 increases by> 200 mL and> 12% compared to baseline
- Experience of dyspnea in the past 7 days
- Age> 18 years old
- Social protection affiliation 5. Written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireMultiDimensional Profile (MDP), Anxiety-Depression Hospital Scale (HADs), Nijmegen | Other | One group (cohort) |
Primary outcome
Description of the sensory and affective dimensions of dyspnea
Time frame: At baseline
MultiDimensional Profile (MDP) scores QS and A2
6 secondary outcomes
Association between dyspnea intensity and asthma control
Time frame: At baseline
Association between dyspnea intensity and anxiety
Time frame: At baseline
Association between dyspnea intensity and hyperventilation
Time frame: At baseline
Association between change in dyspnea intensity and in asthma control
Time frame: Difference between baseline and 6 months
Association between change in dyspnea intensity and in anxiety
Time frame: Difference between baseline and 6 months
Association between change in dyspnea intensity and in hyperventilation
Time frame: Difference between baseline and 6 months
Results and safety
The study was stopped early (reason given: greatly reduced active file of potentially includible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Chenivesse, MD PhD principal investigator
CHU Lille
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University Hospital, Lille at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: greatly reduced active file of potentially includible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the sensory and affective dimensions of dyspnea (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.