Success story in Pulmonology

Therapeutic area:  Asthma

Asthma is a chronic inflammatory disorder of the airways and a serious public health problem worldwide, affecting people of all ages, with an estimate of 300 millions affected individuals.

The occurrence of bronchial asthma has significantly increased for the last 30 years. It is one of the most frequent chronic deceases. In Russia asthma affects approximately 2—7 % of adult people.

 

 Epidemiology

World prevalence of asthma (2003)

: >10,1
: 7,6—10,0
: 5,1—7,5
: 2,5—5,0
: 0—2,4
: There are no data

 

 

Study sponsored by: a leading European pharmaceutical company
Study Description:  adult patients with uncontrolled asthma, 12-weeks treatment period, phase III;
Number of sites in Ukraine: 14 sites.
Study design:  treatment, randomized, double blind (subject, caregiver, investigator, outcomes assessor), active control, parallel assignment, safety/efficacy study
Challenge: complex protocol
Number of involved countries: 4 (EU and Ukraine)
Planned randomized patients for 4 countries: 180 patients during 6 months

 

Results:

1. The recruitment program exceeded the sponsor’s expectations. Enrollment was completed sooner than expected. Ukraine recruited 82% of all planned patients –158 patients were screened, 148 – were randomized (see diagram)

 

2. During the study the sponsor performed an audit.Throughout the auditing the sponsor did not notice any critical or significant violations and the sponsor confirmed that reliable and correct data have been obtained in accordance with the study protocol and GCP guidelines. The sponsor noted the high quality work and the reliability of ESMAR CRAs and CRCs .

 

The sponsor congratulated ESMAR team on the excellent result!