Asthma, Chronic Obstructive Pulmonary Disease (COPD), Asthma-COPD Overlap
Conditions
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 40 to 80 years of age inclusive at the time of signing the informed consent form (ICF). 2. Participant must have either: (A) Asthma Cohort: A physician's diagnosis of asthma and be a regular user of inhaled corticosteroid (ICS) maintenance medication. (B) ACO Cohort: A physician's diagnosis of ACO and be a regular user of long acting muscarinic antagonist (LAMA) and/or long-acting beta-agonist (LABA) and/or ICS maintenance medication. (C) COPD Cohort: A physician's diagnosis of COPD and be a regular user of LAMA and/or LABA maintenance medication. 3. Participant may be male or female. 4. Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Furthermore, adaptive inclusion criteria will be used in order to ensure that a substantial proportion of the study population presents with significant obstructive respiratory disease. In Asthma Cohort: 5. At least 50% of participants must be using an ICS/LABA at Screening. In ACO Cohort and COPD Cohort 6. At least 75% of participants must have a post bronchodilator FEV1/FVC less than 0.7 at Visit 1. AND 7. At least 60% of participants must have experienced an event in the 24 months prior to Screening, where an event includes symptoms of respiratory tract infection requiring antibiotics and/or systemic corticosteroids, exacerbation and asthma attacks. 8. Otherwise (if No.7 is not met), the participants must meet the definition of unstable COPD, as described below: (a) Shortness of breath despite using ICS/LABA medication. (b) Symptoms (such as cough, sputum or shortness of breath) and/or a worsening of symptoms despite using LAMA, LAMA/LABA or ICS/LAMA/LABA medication.
Exclusion criteria
Exclusion criteria: 1. Participant has undergone major lung surgery (e.g. lung reduction, lobectomy, or lung transplant). 2. Participant has a known history of significant inflammatory disease other than COPD (e.g. rheumatoid arthritis or lupus) (ACO Cohort and COPD Cohort only). 3. Participant has serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on participant safety. 4. Participant has been diagnosed with cancer within the last 5 years (participants in remission for 5 years or more are eligible). 5. Participant has a current primary diagnosis of diffuse pan-bronchiolitis, or a primary diagnosis of bronchiectasis or pulmonary fibrosis. 6. Participant only has a diagnosis of chronic bronchitis or pulmonary emphysema and demonstrate no spirometric evidence of obstructive lung disease. 7. Participant is currently participating in another study involving investigational study treatment intervention. Note: If, while enrolled in the present study, the participant enrols in such studies, they will be withdrawn from the present study. 8. Participant is unable to perform spirometry, due to, for example, recent eye surgery or thoracic or abdominal surgery, unstable cardiovascular status, recent myocardial infarction or pulmonary embolism or an allergy to SABAs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| other The proportion of participants presenting with combinations of clinical characteristics, including but not limited to: Example 1: Participants with 30% or more and less than 85% of pre-bronchodilator FEV1, airway reversibility, at least one event in the 24 months prior to Visit 1, 1.5 or more of ACQ-5 score. Example 2: Participants with a smoking history, less than 0.7 of post-bronchodilator FEV1/FVC, at least one event in the 24 months prior to Visit 1, 10 or more of CAAT score, and 100 cells/uL or more of peripheral blood eosinophil. | — |
Secondary
| Measure | Time frame |
|---|---|
| other The proportion of participants presenting with combinations of clinical characteristics at each visit The mean annual rate of events The mean annual rate of moderate and severe exacerbations Pre-and post bronchodilator FEV1, FVC, and FEV1/FVC ratio at each visit Airway reversibility (12% and 200 mL or more increase from pre-bronchodilator FEV1) at each visit CAAT score at each visit ACQ-5 score at each visit SGRQ score at each visit mMRC Dyspnoea Scale score at each visit Proportion of participants experiencing a clinically important deterioration in their obstructive respiratory disease per year Time to lung cancer-related, respiratory-related but not lung cancer-related and all-cause death Lung diffusing capacity measured using DLCO at each visit FeNO at each visit CT scans for evaluating the degree of airways disease and emphysema Total and differential white blood cell count at each visit Proportion of participants with 100 cell/uL or more of peripheral blood eosinophil count at each visit Levels of blood biomarkers associated with respiratory disease progression and outcomes (i.e. Serum hsCRP levels, Serum IgE, Plasma fibrinogen levels) including emerging serum biomarkers measured by clinical laboratory assays available at study completion Medical history and comorbidities (for example: lung cancer, diabetes, cardiovascular disease, osteoporosis) at each visit The proportion of participants whose physician's diagnosis of asthma, ACO or COPD changes during the study Respiratory medications and non-drug therapies received by participants Type of modifications to maintenance medication for asthma/ACO/COPD during the study The proportion of participants who meet the GINA 2018 definition of asthma at each visit: having respiratory symptoms such as wheeze, shortness of breath, chest tightness and/or cough that vary over time and in intensity, and are triggered by factors such as exercise, allergen or irritant exposure The proportion of par | — |
Countries
Japan
Contacts
Public ContactMasayuki Katsumata
GlaxoSmithKline K.K.
Outcome results
None listed