Assessment of small airways involvement in asthma v3.0 21/05/2014
Research type
Research Study
Full title
Assessment of small airways involvement in asthma. Multinational, multicentre, non-pharmacological intervention, cross- sectional and longitudinal study.
IRAS ID
150838
Contact name
Alessandra Gagnatelli
Contact email
Sponsor organisation
CHIESI FARMACEUTICI S.p.A
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
The main purpose of this study is to understand in which way small airways contribute to clinical manifestations of asthma, its severity and disease control. This will be reached through a number of assessments (physical examinations, blood sampling, pulmonary measurements, questionnaires, imaging etc.) done on patients affected by different severity of asthma as well as on normal healthy subjects. 800 asthmatic patients and 100 healthy controls will be recruited from sites in the UK, Germany, Italy, Brazil, China, The Netherlands, Spain, USA and Canada. Each patient will attend 3 study visits over the course of 12 months (each 6 months apart ie visit 2 is 6 months after visit 1 and visit 3 is 6 months after visit 2) during each visit a number of assessments are performed. Two additional phone contacts will be made (at months 3 and 9) with the patient to check medication, questionnaire completion and any safety issues/ concerns.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/1327
Date of REC Opinion
26 Nov 2014
REC opinion
Further Information Favourable Opinion