Asthma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Asthmatic patient inclusion criteria: 1. Male or female patients aged 18 to 65 years, who have signed an Informed Consent form prior to initiation of any study-related procedure; 2. Clinical diagnosis of asthma confirmed by a chest physician according to international guidelines (GINA 2012) supported by objective evidence of variable airflow obstruction and/or bronchodilator reversibility through a documented (in the 5 years prior to baseline visit): 1) positive response to methacholine challenge test [PC20 20%, measured over a follow-up period of 7 days or 4) documented response (defined as dFEV1 =12% and = 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment; 3. Patients on any previous regular asthma treatment (rescue ß2-agonists alone included) at a stable dose for at least 4 weeks prior to baseline visit; 4. Current smoker, ex-smoker (since the past 12 months) or lifelong non-smoker (total lifetime smoking history LLN (lower limit of normal); 5.Normal airways responsiveness: PC20 = 16 mg/mL, PD20 = 1.4
Exclusion criteria
Exclusion criteria: Asthmatic patient exclusion criteria: 1. Cigarette smoking > 10 packyears defined as [(number of cigarettes smoked per day) x (number of years of smoking)]/20; 2. Clinical history of COPD.3.Asthma exacerbation in the 4 weeks prior to baseline visit (defined as a significant deterioration of asthma and signalled by any or more of the following: need for a systemic corticosteroid course (>3 days); hospitalisation for asthma; emergency room attendance for asthma); 4. Clinical or functional uncontrolled respiratory (other than asthma), haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might, in the judgment of the investigator, compromise the results or interpretation of the study; 5. Pregnant or lactating women (a urine pregnancy test will be performed); 6. Participation in an interventional clinical trial with intake of the last dose of any investigational drug 10 packyears defined as [(number of cigarettes smoked per day) x (number of years of smoking)] / 20. 2. Clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might, in the judgment of the investigator, compromise the results or interpretation of the study; 3. Pregnant or lactating women (a urine pregnancy test will be performed); 4. Participation in an interventional clinical trial with intake of the last dose of any investigational drug <12 weeks preceding baseline visit (last dose < 5 half-lives prior to baseline visit for biologics); 5. Inclusion in another clinical trial with an investigational drug during the course of the present study; 6. Inability to comply with study procedures; 7. Alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % wall area;pi10WA;Percent voxels less than -850Hu; | — |
Countries
China
Contacts
The first affiliated hospital of Guangzhou Medical University