A single centre, randomised, double-blind, double-dummy, placebo-and active-controlled, 3-way cross-over study to evaluate the 24 hour FEV1 profile of a single dose of CHF 5188 pMDI (400/4 mcg QD) (fixed combination budesonide/carmoterol 200/2 mcg) in adults patients with moderate or severe persistent asthma

Chiesi Farmaceutici SpA0 sites42 target enrollmentJuly 15, 2008

Overview

No summary available.

Registry

who.int

Start Date

July 15, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Written Informed Consent Obtained
•2\. Male or female patients aged \> or \= 18 years
•3\. Patients with moderate or severe asthma not optimally controlled according to the GINA 2005 classification of asthma severity by daily medication regimen and response to treatment
•4\. Patients already treated with inhaled cortiscosteroids at stable dose for at least 4 weeks prior to inclusion
•5\. Patients with Forced Expiratory Volume in the first second (FEV1\) \= 50% and \= 90% of predicted for the patient normal value and not less than 0\.9 L in absolute value
•6\. Patients with a documented positive response to the reversibility test, defined as an increase of at least 12% and at least 200 mL from pre\-dosing values in the measurement of FEV1 within 30 minutes after the inhalation of 400 µg salbutamol pMDI
•7\. Patients with a co\-operative attitude and ability to be trained to correctly use the pMDI and the Turbuhaler®.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Patients will not be enrolled at Visit 1 into the run\-in period if they meet any of the following criteria:
•1\. Inability to carry out pulmonary function testing;
•2\. Diagnosis of COPD as defined by the current GOLD guidelines;
•3\. Current smokers or ex\-smokers with total cumulative exposure equal or more than 5 pack\-years and/or having stopped smoking one year or less prior to study start;
•4\. History of near fatal asthma or of a past hospitalisation for asthma in ICU;
•5\. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks (e.g. oral corticosteroids intake);
•6\. Patients presenting with 3 or more asthma exacerbations in the previous year;
•7\. Hospitalisation due to asthma during the previous 8 weeks;
•8\. History of significant seasonal variation of asthma;
•9\. Patients treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 8 weeks;