Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE:
In asthmatic subjects, smoking can lead to several changes in disease characterictics. in smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Increasing data support the concept that ACOS is a clinical entity. However, this should be further studied in order to better target therapy.
AIM:
The objective of this study is to evaluate the comparative features of ACOS
METHODS:
This will be a descriptive study comparing the features of the ACOS with the features of asthmatic subjects with an incomplete reversibility of airway obstruction (IRAO).The study will be done over 1 or 2 visits (within a week interval), according to subjects' availability. The visit will include completion of different questionnaires (asthma control asthma quality of life, medical history, exacerbations, etc.), a thoracic examination, allergy skin-prick tests, spirometry and bronchodilator response, lung volumes and compliance measurements, exhaled nitric oxide measurement, blood sampling and a sputum induction.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACOS smoking history >20 pack-years | Subjects with asthma-COPD overlap syndrome | ||
| IRAO smoking history <5 pack-years | Subjects with an incomplete reversibility of airway obstruction |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Total asthma control questionnaire (ACQ) score | Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry results | Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC | Baseline |
| Sputum eosinophil percentage | Percentage of sputum eosinophils |
Not provided
Inclusion Criteria:
ALL SUBJECTS
ACOS SUBJECTS
1. Smokers or ex-smokers of at least 20 pack-years. 2. With an IRAO (see definitions section). IRAO SUBJECTS
Exclusion Criteria:
ALL SUBJECTS
Not provided
Not provided
Not provided
Asthmatic subjects will be recruited from the asthma outpatient clinic, from participation to past research studies, or from advertisements.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Louis-Philippe Boulet, MD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec | Québec | Quebec | G1V 4G5 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 29, 2020 | |
| Reset | Nov 20, 2020 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 29, 2020 | Nov 20, 2020 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Sputum and blood
| Baseline |
| Concentration of Blood biomarkers | alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen | Baseline |
| Asthma quality of life questionnaire (AQLQ) score | Measurement of asthma quality of life using the Mini asthma quality of life questionnaire. It is a 7-point scale questionnaire (where 1 is greatest impairment and 7 is least impairment) containing 15 uqestions divided into 4 domains : symptoms (5 items), activity limitation (4 items), emotional function (3 items), and exposure to environmental stimuli (3 items). during the last 2 weeks. The overall score is the mean of all the responses. Each domain score is calculated from the mean of the items that relate to it. | Baseline |
| Number of patients with comorbidities | gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression | Baseline |
| Number of asthma exacerbations in the previous year | emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits | Baseline |
| Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up | Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better. | Baseline to one-year follow-up |
| Change from baseline number of exacerbations at one-year follow-up | emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits | Baseline to one-year follow-up |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |