The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome

Laval University115 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

115

Conditions

Asthma COPD

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: ALL SUBJECTS 1. Subjects aged 45 years and older. 2. Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests. 3. Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication. 4. Free of respiratory infection in the 4 weeks preceding the study. 5. No changes in the asthma and COPD-related medications in the 4 weeks preceding the study. 6. If female, not pregnant (or lactating). 7. Able to adhere to study procedures. 8. 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 1\. Smokers or ex-smokers of at least 20 pack-years. 2. With an IRAO (see definitions section). IRAO SUBJECTS 1. 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. 2. With an IRAO. Exclusion Criteria: * ALL SUBJECTS 1. With COPD without a past diagnosis of asthma. 2. Unstable respiratory or non-respiratory condition. 3. Any active chronic inflammatory disease. 4. Any evidence of malignancy (active and/or treated) within the previous 5 years. 5. Any significant concomitant illness or injury that would interfere with the subject's participation in the study. 6. Any history of bronchial thermoplasty. IRAO SUBJECTS  1. Use of any nicotine containing product within 1 year prior to study entry or a smoking history of \> 5 pack-years.

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes

Spirometry results

Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC

Time frame: Baseline

Sputum eosinophil percentage

Percentage of sputum eosinophils

Time frame: Baseline

Concentration of Blood biomarkers

alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen

Time frame: 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.

Time frame: Baseline

Number of patients with comorbidities

gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression

Time frame: Baseline

Number of asthma exacerbations in the previous year

emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits

Time frame: Baseline

Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up

Time frame: 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

Time frame: Baseline to one-year follow-up

The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes