Asthma
Conditions
Brief summary
Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.
Detailed description
Large non pharmacological studies on Small Airways Disease
Interventions
None listed
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Asthmatic patient inclusion criteria 1. Male or female patients aged ≥ 18 and ≤ 65 years, who have signed an Informed Consent form 2. Clinical diagnosis of asthma f 1. Positive response to methacholine challenge test 2. Positive response to a reversibility test or 3. Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) \> 20% or 4. Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment. 3. Patients with stable asthma. 4. Current smoker, ex-smoker or lifelong non-smoker Healthy subject inclusion criteria 1\. Male or female patients aged ≥ 18 and ≤ 65 years 2. No clinical history of asthma or COPD 3. Current smoker, ex-smoker or lifelong non-smokers 4. Normal spirometry 5. Normal airways responsiveness Asthmatic patient
Exclusion criteria
1. Cigarette smoking \> 10 packyears 2. diagnosis of COPD 3. Asthma exacerbation in the 8 weeks prior to baseline visit 4. Clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might compromise the results or interpretation of the study. 5. Pregnant or lactating women 6. Participation in an interventional clinical trial \<12 weeks preceding baseline visit 7. Inability to comply with study procedures. 8. Alcohol or drug abuse. Healthy subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the role of small airways abnormalities in the clinical manifestations of asthma. | 1 year |
Countries
Brazil, Canada, China, Germany, Italy, Netherlands, Spain, United States
Contacts
PRINCIPAL_INVESTIGATORMonica Kraft, MD
Duke University
PRINCIPAL_INVESTIGATORDirkje S Postma, Prof. Dr.
University Medical Center Groningen
Outcome results
None listed