A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS

Phase 4

Completed

Conditions: asthma
lung inflammation
10024967

Registration Number: NL-OMON33799

Lead Sponsor: Chiesi Farmaceutici

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 110

Inclusion Criteria

Written informed consent obtained from adult male or female (*18 and *65 years) patients with a clinical diagnosis of controlled asthma according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2007 in the previous week before study entry ( no daytime symptoms (twice or less/week):
- no limitations of activities
- no nocturnal symptoms/awakenings
- no need for reliever/rescue medications (twice or less/week)
- lung function (FEV1) > 80% predicted or personal best (if known), patients treated with fluticasone 500 µg + salmeterol 100 µg daily for * 4 weeks
A co-operative attitude and ability to correctly use the device and to complete the diary cards.

Exclusion Criteria

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 Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines;
3. History of near fatal asthma;
4. Evidence of severe asthma exacerbation or symptomatic infection of the lower airways in the previous six months;
5. Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
6. Patients treated with long-acting *2-agonists (LABAs) other than salmeterol, anticholinergics, and leukotriene antagonists during the previous 4 weeks;
7. Current smokers or recent (less than one year) ex-smokers defined as smoking at least 15 packs/year;
8. 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;
9. Patients with a serum potassium value * 3.5 mEq/L
10. Patients with QTc interval (Bazett*s formula) higher than 450 msec at screening visit 1;
11. Cancer or any chronic diseases with prognosis < 2 years;
12. 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
13. Significant alcohol consumption or drug abuse;
14. Patients treated with beta-blockers as regular use;
15. Patients treated with monoamine oxidase inhibitor, tricyclic antidepressants and Selective Serotonin Re-uptake Inhibitors (SSRIs), unless already taken at stable doses at the screening visit
16. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
17. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
18. Patients who received any investigational new drug within the last 12 weeks;
19. Patients with asthma exacerbations during the run-in period will also be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pre-dose morning forced expiratory volume in one second (FEV1) measured at the<br /><br>last clinic visit.<br /><br>See page 42 from the protocol.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> The following variables will be evaluated as secondary efficacy endpoints:<br /><br><br /><br>* Other pulmonary function tests measured at clinics (FEV1, PEF, FVC,<br /><br>FEF25-75%);<br /><br>* FEV1 area under the curve (AUC) in the first hour post-dose measured at<br /><br>clinics at visit 2 and visit 5<br /><br>* ACQ score at clinic visits 1, 2 (baseline) and 5<br /><br>* Use of rescue medication;<br /><br>* Number of patients with controlled or partly controlled asthma at clinic<br /><br>visits according to GINA guidelines revised version 2007;<br /><br>* Days without asthma symptoms (%), days without use of rescue medication (%)<br /><br>and daily asthma symptoms* score from diary cards<br /><br>* Pharmacoeconomic analyses assessing differences in direct medical costs<br /><br>(healthcare perspective) and in both direct healthcare and indirect costs<br /><br>(societal perspective).<br /><br><br /><br>See page 42 from the protocol.<br /><br><br /><br></p><br>