A SINGLE-DOSE, OPEN-LABEL, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 HFA pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 50µg PLUS FORMOTEROL FUMARATE 6 µg ) USING THE AEROCHAMBER PLUS™ SPACER DEVICE VERSUS THE FREE COMBINATION OF BECLOMETHASONE HFA pMDI AND FORMOTEROL HFA pMDI AVAILABLE ON THE MARKET USING THE AEROCHAMBER PLUS™ SPACER DEVICE IN ASTHMATIC CHILDRE

• Conditions: Asthmatic children, aged 5-11, with a forced expiratory volume in one second (FEV1) > 70% of predicted values.; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2009-010434-22-DK
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-20
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting) prior to any study-related procedures.
2. Male/female children with asthma stable enough, according the paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
3.Male/female children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonist as reliever to control asthma symptoms
4. Age 5 -11y (about 50% of the 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).
6. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Exclusion Criteria
The presence of any of the following will exclude a subject from study enrolment:
1. Past or present diagnoses 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 inclusion
6. Lower respiratory tract infection within 1 month prior to inclusion
7. Disease (other than asthma) which might influence the outcome of the study
8. Obesity, i.e. > 97% weight percentile by local standards

Study & Design

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