Multidimensional Assessment of Dyspnea in Asthma (MIDAS)

January 23, 2023 updated by: University Hospital, Lille

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Dunkerque, France
        • Ch Dunkerque
      • Lille, France, 59037
        • Hopital Saint Vincent - Saint Antoine - Lille
      • Lille, France
        • Hop Calmette Chu Lille
      • Paris, France
        • Hu Paris Nord Site Bichat Aphp - Paris 18
      • Paris, France
        • Hu Paris Sud Site Kremlin Bicetre Aphp - Le Kremlin Bicetre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Asthmatic patients reporting breathlessness

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
One group (cohort)
Asthmatic patients
Other: Questionnaire
MultiDimensional Profile (MDP), Anxiety-Depression Hospital Scale (HADs), Nijmegen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Description of the sensory and affective dimensions of dyspnea
Time Frame: At baseline
MultiDimensional Profile (MDP) scores QS and A2
At baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association between dyspnea intensity and asthma control
Time Frame: At baseline
Correlation between MDP scores QS and A2 and ACQ-5 Correlation between MDP scores QS and A2 and ACQ-5
At baseline
Association between dyspnea intensity and anxiety
Time Frame: At baseline
Correlation between MDP scores QS and A2 and anxiety score HAD-A
At baseline
Association between dyspnea intensity and hyperventilation
Time Frame: At baseline
Correlation between MDP scores QS and A2 and the Nijmegen score
At baseline
Association between change in dyspnea intensity and in asthma control
Time Frame: Difference between baseline and 6 months
Correlation between change in MDP scores QS and A2 and change in ACQ-5
Difference between baseline and 6 months
Association between change in dyspnea intensity and in anxiety
Time Frame: Difference between baseline and 6 months
Correlation between change in MDP scores QS and A2 and change in HAD-A score
Difference between baseline and 6 months
Association between change in dyspnea intensity and in hyperventilation
Time Frame: Difference between baseline and 6 months
Correlation between change in MDP scores QS and A2 and change in the Nijmegen score
Difference between baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cécile Chenivesse, MD PhD, CHU Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019_11
  • 2019-A02795-52 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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