Bronchial asthma
Conditions
Interventions
Cohort A:non-smokers, non-asthmatic with prebronchodilator Forced expiratory volime in 1 second (FEV1) =80% predicted.
Cohort B:mild asthmatics on as-needed low dose inhaled corticosteroids (ICS)-formoterol, or low dose ICS plus as-needed short-acting ß2 agonists (SABA), without the need for other controller medicatio
Cohort C:up to 600 moderate to severe asthamatics on low or medium dose ICS-long acting ß2 agonists (LABA), high dose alone or in combination with LABA with prebronchodilator FEV1=80% predicted.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria:Capable of giving signed informed consent.;Participant must be 18 to 75 years of age inclusive, at the time of signing the ICF.;Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society (ATS) and European Respiratory Society (ERS) 2019 acceptability criteria.;Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 3.4.1 General Exclusion Criteria for All Cohorts 1. The participant has a history of alcohol or drug abuse within the past year, which, in the opinion of the responsible physician, contra-indicates their participation. 2. As a result of medical interview, physical examination or screening investigation the physician responsible considers the participant unfit for the study either because of the risk to the participant due to the study or the influence this may have on the study results. 3. Participants is female who is pregnant. If a woman is subsequently found to have been pregnant at the time of an assessment, data from that assessment will not be included in the analyses. 4. The participant has an altered mental status at the time of informed consent. 5. Receipt marketed or investigational biologics within 3 months or 5 half-lives prior to visit 1, whichever is longer. 6. Receipt LTRAs or 5-lipoxygenase (5-LO) inhibitors (eg zileuton and montelukast) within 1 month or 5 half-lives prior to visit 1, whichever is longer. 7. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments (assessments should be deferred) 8. Terminal disease and/or organ failure or participants otherwise considered not appropriate for the study participation. 3.4.2 Additional Exclusion Criteria for All Asthma Cohorts 1. Participant has changed asthma medication within the 4 weeks prior to screening (except those using symbicort maintenance and reliever therapy [SMART] regime). 2. Participant had an asthma exacerbation (requiring use of systemic corticosteroids or a temporary increase in a stable oral corticosteroid background dose for at least 3 days) in the previous 2 weeks. 3. Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma). 4. Any clinically important pulmonary disease other than asthma (eg, active lung infection, Chronic Obstructive Pulmonary Disease [COPD], bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome.5. Radiological findings of solitary pulmonary nodules without appropriate follow-up and demonstration of stability as per standard of care, or findings suggestive of acute infection. 6. Diagnosis or current investigation of occupational asthma. 7. Diagnosis of chronic inflammatory diseases other than asthma (inflammatory bowel disease, rheumatoid arthritis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify novel phenotypes and endotypes by their associations with differential outcomes,; | — |
Countries
China
Contacts
Public ContactGang Wang
West China Hospital of Sichuan University
Outcome results
None listed