A Study of CHF 1535 100/6 Next DPI® In Asthmatic Patients
Research type
Research Study
Full title
A MULTICENTER, MULTINATIONAL, SINGLE-DOSE, OPEN LABEL, RANDOMIZED, 2-WAY CROSSOVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 100/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg) VERSUS THE FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI IN ASTHMATIC ADOLESCENTS AND ADULTS PATIENTS
IRAS ID
56208
Contact name
Dave Singh
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2010-018947-33
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
Research summary
Short Study Title: A Study of CHF 1535 100/6 NEXT DPI© Versus Licensed Beclomethasone DPI and Formoterol DPI In Asthmatic PatientsAsthma is a serious public health problem throughout the world, affecting people of all ages. The disease is characterised by a chronic airway inflammation associated with airway hyperresponsiveness and leading to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. Chiesi Farmaceutici S.p. A., a pharmaceutical company is developing a new dry powder inhaler for Asthmatic patients, called NEXT DPI©, which contains a combination of 2 drugs called beclomethasone and formoterol. Chiesi Company already developed this fixed combination in a HFA formulation as pMDI inhaler and it has been marketed in 27 Countries in Europe. This multicenter, multinational research study will compare the amount of study drug in a patient??s blood after administration of these drugs delivered via the new NEXT DPI© dry powder inhaler in comparison to the free (separate) combination between beclomethasone and formoterol delivered via two already marketed dry powder inhalers. Information on the safety and tolerability of the treatments will also be assessed. The study is due to last for about 13 months. It is expected that approximately 24 adolescent (between 12 and 17) and 24 adult (between 18 and 65 years old) patients, who are non-smoking asthmatics, will participate in the study. Each patient will participate for approximately 3-12 weeks. Participants will be randomised (chosen by chance, like the flip of a coin) into 2 different treatment groups by a computer, and a cross-over study design will enable each group to have the different treatments in turn. Patients will need to visit the research clinic 3-4 times whilst they are in the study, during which time they will undergo the following study procedures: medical history recorded, physical examinations, vital signs recorded, lung function tests, and blood samples collected for laboratory safety tests. It is hoped that the results from this study will help the future treatment of asthmatic adolescent and adult patients.
REC name
North West - Haydock Research Ethics Committee
REC reference
10/H1010/41
Date of REC Opinion
23 Aug 2010
REC opinion
Further Information Favourable Opinion