A SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE 50 µg PLUS FORMOTEROL FUMARATE 6 µg ) VERSUS THE FREE COMBINATION OF LICENSED BECLOMETASONE DPI AND FORMOTEROL DPI IN ASTHMATIC CHILDRE

Conditions: Asthmatic children aged = 5 and < 12 yearsA part of the asthamatic children (8-10) must be in age range 5-8 years old in order to guarantee a complete representation.
MedDRA version: 14.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-001208-36-DK

Lead Sponsor: Chiesi Farmaceutici S.p.A

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 26

Inclusion Criteria

Patients will be eligible for enrolment if they meet all of the following criteria:
1.Written informed consent obtained by Parent/Legal Representative (according to local regulation) and by the minor (age and local regulation permitting).
2.Male/female children with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments
3.Male/female children with asthma receiving regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
4.Age = 5 < 12 years (8 to 10 children in the age range 5-8 years old)
5.Children with a forced expiratory volume in one second (FEV1)>70% of predicted values (% pred) after withholding ?2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
6.A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures.

Are the trial subjects under 18? yes
Number of subjects for this age range: 26
F.1.2 Adults (18-64 years) no
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

Patients will not be enrolled if one or more of the following criteria are present:
1.Past or present diagnosis of cardiovascular, renal or liver disease
2.Known hypersensitivity to the active treatments
3.Exacerbation of asthma symptoms within the previous 4 weeks
4.Inability to perform the required breathing technique and blood sampling
5.Hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1)
6.Lower respiratory tract infection within 1 month prior to screening (visit 1)
7.Disease (other than asthma) which might influence the outcome of the study
8.Obesity, i.e. > 97% weight percentile by local standards