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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

CHF1535 pMDI + AC Plus

BDP + AC Plus

Formoterol + AC Plus

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, ICS+LABA, Children, Inhalation, pMDI

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept 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

Sites / Locations

BorneAstmaKlinikken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHF1535 pMDI + AC Plus

BDP and Formoterol + AC Plus

Arm Description

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

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

Outcomes

Primary Outcome Measures

B17MP AUC0-t

B17MP (active metabolite of BDP) systemic exposure as AUC0-t

Secondary Outcome Measures

B17MP PK profile

BDP PK prolile

Formoterol PK profile

Plasma potassium AUC, Cmin, tmin

Plasma potassium to evaluate drug systemic effect

Urinary Cortisol excretion

8h urinary excretion of cortisol and 8h urinary excretion of cortisol normalized for 8h creatinine excretion to evaluate dru systemic effects

Glucose in urine

Glucose to evaluate the drug systemic effects

Heart rate Time averaged heart rate value (AUC0-t)/t

Heart rate to evaluate the drug systemic effects

Spirometry: PEF

Peak respiratory flow as a measure of drug efficacy

Full Information

NCT ID

NCT01848769

First Posted

May 3, 2013

Last Updated

July 30, 2020

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT01848769

Brief Title

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

Acronym

PAED1

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 Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, ICS+LABA, Children, Inhalation, pMDI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHF1535 pMDI + AC Plus

Arm Type

Experimental

Arm Description

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

Arm Title

BDP and Formoterol + AC Plus

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CHF1535 pMDI + AC Plus

Other Intervention Name(s)

Fixed combination of BDP and FF 50/6 mcg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

BDP + AC Plus

Other Intervention Name(s)

Beclomethasone Dipropionate 50 mcg with Aerochamber Plus

Intervention Description

Four inhalations for a total dose of BDP 200 mcg

Intervention Type

Drug

Intervention Name(s)

Formoterol + AC Plus

Other Intervention Name(s)

Formoterol 6 mcg with Aerochamebr Plus

Intervention Description

Four inhalations for a total dose of Formoterol 24 mcg

Primary Outcome Measure Information:

Title

B17MP AUC0-t

Description

B17MP (active metabolite of BDP) systemic exposure as AUC0-t

Time Frame

pre-dose until 8hours post dose

Secondary Outcome Measure Information:

Title

B17MP PK profile

Time Frame

pre-dose until 8 hours post-dose

Title

BDP PK prolile

Time Frame