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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01848769

Acronym

PAED1

Enrollment

Registered

2013-05-07

Start date

2009-09-30

Completion date

2010-12-31

Last updated

2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, ICS+LABA, Children, Inhalation, pMDI

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).

Interventions

DRUGCHF1535 pMDI + AC Plus

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

DRUGBDP + AC Plus

Four inhalations for a total dose of BDP 200 mcg

DRUGFormoterol + AC Plus

Four inhalations for a total dose of Formoterol 24 mcg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 11 Years

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. 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

Design outcomes

Primary

Measure	Time frame	Description
B17MP AUC0-t	pre-dose until 8hours post dose	B17MP (active metabolite of BDP) systemic exposure as AUC0-t

Secondary

Measure	Time frame	Description
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
B17MP PK profile	pre-dose until 8 hours post-dose	—
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
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026