Multidimensional Assessment of Dyspnea in Asthma

NCT04286906 | Terminated

• 2 other identifiers: 2019_112019-A02795-52
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 5

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.

Conditions

Asthma

Keywords

Asthma; Breathlessness

Outcome Measures

Primary Outcomes (1)

• Description of the sensory and affective dimensions of dyspnea

  MultiDimensional Profile (MDP) scores QS and A2

  At baseline

Secondary Outcomes (6)

• Association between dyspnea intensity and asthma control

  At baseline

• Association between dyspnea intensity and anxiety

  At baseline

• Association between dyspnea intensity and hyperventilation

  At baseline

• Association between change in dyspnea intensity and in asthma control

  Difference between baseline and 6 months

• Association between change in dyspnea intensity and in anxiety

  Difference between baseline and 6 months

Study Arms (1)

One group (cohort)

Asthmatic patients

Other: Questionnaire

Interventions

Questionnaire OTHER

MultiDimensional Profile (MDP), Anxiety-Depression Hospital Scale (HADs), Nijmegen

One group (cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asthmatic patients reporting breathlessness

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years old
• Active smoker or quitting smoking for less than a year
• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (5)

Ch Dunkerque

Dunkirk, France

Location

Hopital Saint Vincent - Saint Antoine - Lille

Lille, 59037, France

Location

Hop Calmette Chu Lille

Lille, France

Location

Hu Paris Nord Site Bichat Aphp - Paris 18

Paris, France

Location

Hu Paris Sud Site Kremlin Bicetre Aphp - Le Kremlin Bicetre

Paris, France

Location

MeSH Terms

Conditions

Asthma; Dyspnea

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cécile Chenivesse, MD PhD

  CHU Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 27, 2020
• Study Start: May 18, 2020
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)