The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome
The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome: A Comparison of Asthma Outcomes in Smoking vs Non-smoking Patients With an Incomplete Reversibility of Airway Obstruction (IRAO)
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.
Przegląd badań
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Quebec, Kanada, G1V 4G5
- Institut Universitaire de cardiologie et de pneumologie de Quebec
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
ALL SUBJECTS
- Subjects aged 45 years and older.
- Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests.
- Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication.
- Free of respiratory infection in the 4 weeks preceding the study.
- No changes in the asthma and COPD-related medications in the 4 weeks preceding the study.
- If female, not pregnant (or lactating).
- Able to adhere to study procedures.
- 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
- 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.
- With an IRAO.
Exclusion Criteria:
ALL SUBJECTS
- With COPD without a past diagnosis of asthma.
- Unstable respiratory or non-respiratory condition.
- Any active chronic inflammatory disease.
- Any evidence of malignancy (active and/or treated) within the previous 5 years.
- Any significant concomitant illness or injury that would interfere with the subject's participation in the study.
- Any history of bronchial thermoplasty. IRAO SUBJECTS
- Use of any nicotine containing product within 1 year prior to study entry or a smoking history of > 5 pack-years.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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ACOS smoking history >20 pack-years
Subjects with asthma-COPD overlap syndrome
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IRAO smoking history <5 pack-years
Subjects with an incomplete reversibility of airway obstruction
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Total asthma control questionnaire (ACQ) score
Ramy czasowe: Baseline
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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.
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Baseline
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Spirometry results
Ramy czasowe: Baseline
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Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC
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Baseline
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Sputum eosinophil percentage
Ramy czasowe: Baseline
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Percentage of sputum eosinophils
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Baseline
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Concentration of Blood biomarkers
Ramy czasowe: Baseline
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alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen
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Baseline
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Asthma quality of life questionnaire (AQLQ) score
Ramy czasowe: Baseline
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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.
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Baseline
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Number of patients with comorbidities
Ramy czasowe: Baseline
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gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression
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Baseline
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Number of asthma exacerbations in the previous year
Ramy czasowe: Baseline
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emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
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Baseline
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Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up
Ramy czasowe: Baseline to one-year follow-up
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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.
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Baseline to one-year follow-up
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Change from baseline number of exacerbations at one-year follow-up
Ramy czasowe: Baseline to one-year follow-up
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emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
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Baseline to one-year follow-up
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CÉR21047
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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