Effect of beclomethasone dipropionate/formoterol fumarate (BDP+FF) administered as a fixed pMDI combination on lung impedance and exhaled nitric oxide in comparison with the fixed combination of budesonide and formoterol fumarate (Symbicort Turbohaler®). FLEX study (Foster fixed combination on Lung Impedance and Exhaled nitric oXide)A single-centre, randomized, double blind, double-dummy, two-way cross-over, repeated dose study

• Conditions: Bronchial Asthma; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2008-005707-26-DE
• Lead Sponsor: Chiesi Farmaceutici SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-12
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Written informed consent obtained
2. Adult male and female (=18 and =65 years)
3. Clinical diagnosis of Asthma according to Global Strategy for Asthma
management and Prevention (GINA) revised version 2007
4. Patients treated with inhaled corticosteroids equivalent to Budesonide 200
µg b.i.d. (with or without LABA), including fixed combination
5. FEV1 = 65% of the predicted normal value pre-bronchodilator
6. A documented positive response to the reversibility test, defined as an
improvement in FEV1 of at least 12% from baseline value and 200 ml 30
minutes after 4 puffs of inhaled salbutamol pMDI (400 µg) at screening or
within a year prior to screening and/or documented hyper-responsiveness to methacholine on bronchial challenge testing
7. FENO > 30 ppb at screening. If this test fails, it can be repeated once
(Screening Visit 1 rescheduled within 7 days. In this case, only NO
measurement will be re-performed)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Inability to carry out pulmonary function testing and NO testing;
2. Diagnosis of COPD as defined by the current GOLD guidelines (2006);
3. History of near fatal asthma;
4. Evidence of severe asthma exacerbation or symptomatic infection of the
airways in the previous 8 weeks;
5. More than two courses of oral corticosteroids or hospitalisation due to asthma
during the previous 6 months;
6. Current smokers or recent (less than one year) ex-smokers defined as smoking
more than 10 pack-years;
7. Clinically significant or unstable concurrent disease: e.g. uncontrolled
hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease;
significant hepatic impairment; significant renal impairment; significant other
pulmonary disease; cardiovascular disease; gastrointestinal disease;
neurological disease; haematological disease, autoimmune disorders, that may
interfere with patient’s safety, compliance, or study evaluations, according to
the investigator’s opinion;
8. Cancer or any chronic diseases with prognosis < 2 years;
9. Female subjects: pregnant or with active desire to be pregnant, lactating
mother or lack of efficient contraception in a subject with child-bearing
potential (i.e. contraceptive methods other than oral contraceptives, IUD, tubal
ligature). A pregnancy test in urine is to be carried out in women of a fertile
age at screening;
10. Significant alcohol consumption or drug abuse;
11. Patients treated with leukotrien modifiers, inhaled long-acting and shortacting
anticholinergics, monoamine oxidase inhibitors or beta-blockers as
regular use
12. Patients treated with tricyclic antidepressants or Selective Serotonin Reuptake
Inhibitors (SSRIs) unless already taken at stable doses at the screening
visit;
13. Patients treated with extrafine formulations of ICS or fixed combinations of
ICS and LABA
14. Allergy, sensitivity or intolerance to study drugs and/or study drug
formulation ingredients;
15. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
16. Patients who received any investigational new, not yet approved drugs within
the last 8 weeks.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified