Trial | NCT01848769  Report issue

Title

Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
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 Children

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).
Study Started
Sep 30
2009
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Jul 31
2020

Drug CHF1535 pMDI + AC Plus

Four inhalations for a total dose of BDP/FF 200/24 mcg

  • Other names: Fixed combination of BDP and FF 50/6 mcg

Drug BDP + AC Plus

Four inhalations for a total dose of BDP 200 mcg

  • Other names: Beclomethasone Dipropionate 50 mcg with Aerochamber Plus

Drug Formoterol + AC Plus

Four inhalations for a total dose of Formoterol 24 mcg

  • Other names: Formoterol 6 mcg with Aerochamebr Plus

CHF1535 pMDI + AC Plus Experimental

Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device

BDP and Formoterol + AC Plus Active Comparator

Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device

Criteria 

Inclusion Criteria:

Male/Female children aged 5-11 years
Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
children with stable asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms

Forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period.

6. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.

Exclusion Criteria:

Past or present diagnoses of cardiovascular, renal or liver disease
Known hypersensitivity to the active treatments
Exacerbation of asthma symptoms within the previous 4 weeks
Inability to perform the required breathing technique and blood sampling
Hospitalization due to exacerbation of asthma within 1 month prior to inclusion
Lower respiratory tract infection within 1 month prior to inclusion
Disease (other than asthma) which might influence the outcome of the study
Obesity, i.e. > 97% weight percentile by local standards
No Results Posted