PAED1: Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old

Sponsor

Chiesi Farmaceutici S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01848769

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: CHF1535 pMDI + AC Plus Drug: BDP + AC Plus Drug: Formoterol + AC Plus	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHF1535 pMDI + AC Plus Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device	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
Active Comparator: BDP and Formoterol + AC Plus Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device	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

Arm

Intervention/Treatment

Experimental: CHF1535 pMDI + AC Plus

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

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

Active Comparator: BDP and Formoterol + AC Plus

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

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

Outcome Measures

Primary Outcome Measures

B17MP AUC0-t [pre-dose until 8hours post dose]
B17MP (active metabolite of BDP) systemic exposure as AUC0-t

Secondary Outcome Measures

B17MP PK profile [pre-dose until 8 hours post-dose]
BDP PK prolile [Pre-dose until 8 hours post-dose]
Formoterol PK profile [Pre-dose until 8 hours post-dose]
Plasma potassium AUC, Cmin, tmin [Pre-dose until 8 hours post-dose]
Plasma potassium to evaluate drug systemic effect
Urinary Cortisol excretion [Pre-dose until 8 hours post-dose]
8h urinary excretion of cortisol and 8h urinary excretion of cortisol normalized for 8h creatinine excretion to evaluate dru systemic effects
Glucose in urine [Pre-dose until 8 hours post-dose]
Glucose to evaluate the drug systemic effects
Heart rate Time averaged heart rate value (AUC0-t)/t [Pre-dose until 8 hours post-dose]
Heart rate to evaluate the drug systemic effects
Spirometry: PEF [Pre-dose until 8 hours post-dose]
Peak respiratory flow as a measure of drug efficacy

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.