The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome
Study Details
Study Description
Brief Summary
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Total asthma control questionnaire (ACQ) score [Baseline]
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.
Secondary Outcome Measures
- Spirometry results [Baseline]
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC
- Sputum eosinophil percentage [Baseline]
Percentage of sputum eosinophils
- Concentration of Blood biomarkers [Baseline]
alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen
- Asthma quality of life questionnaire (AQLQ) score [Baseline]
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.
- Number of patients with comorbidities [Baseline]
gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression
- Number of asthma exacerbations in the previous year [Baseline]
emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
- Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up [Baseline to 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.
- Change from baseline number of exacerbations at one-year follow-up [Baseline to one-year follow-up]
emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
Eligibility Criteria
Criteria
Inclusion Criteria:
ALL SUBJECTS
-
Subjects aged 45 years and older.
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Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests.
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Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication.
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Free of respiratory infection in the 4 weeks preceding the study.
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No changes in the asthma and COPD-related medications in the 4 weeks preceding the study.
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If female, not pregnant (or lactating).
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Able to adhere to study procedures.
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Able and willing to provide written informed consent to participate in the study, in accordance with international conference on harmonization (ICH) good clinical practice (GCP) requirements.
ACOS SUBJECTS
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Smokers or ex-smokers of at least 20 pack-years. 2. With an IRAO (see definitions section). IRAO SUBJECTS
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Long-life non-smokers or ex-smokers defined as someone who smoked less than 5 pack-years and who completely stopped smoking for at least 12 months before inclusion in the study.
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With an IRAO.
Exclusion Criteria:
- ALL SUBJECTS
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With COPD without a past diagnosis of asthma.
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Unstable respiratory or non-respiratory condition.
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Any active chronic inflammatory disease.
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Any evidence of malignancy (active and/or treated) within the previous 5 years.
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Any significant concomitant illness or injury that would interfere with the subject's participation in the study.
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Any history of bronchial thermoplasty. IRAO SUBJECTS
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Use of any nicotine containing product within 1 year prior to study entry or a smoking history of > 5 pack-years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut universitaire de cardiologie et de pneumologie de Québec | Quebec | Canada | G1V 4G5 |
Sponsors and Collaborators
- Laval University
Investigators
- Principal Investigator: Louis-Philippe Boulet, MD, Laval University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CÉR21047