Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versu... | NCT01848769

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

NCT01848769

Sponsor

Chiesi Farmaceutici S.p.A.

Status

Completed

Last Update Posted

Jul 31, 2020Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Asthma

Interventions

CHF1535 pMDI + AC Plus
BDP + AC Plus
Formoterol + AC Plus

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

May 3, 2013

First Submission Date that Met QC Criteria

May 3, 2013

First Posted Date

May 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2020

Last Update Posted Date

Jul 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CHF1535 pMDI + AC Plus	Experimental	Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device	Drug: CHF1535 pMDI + AC Plus
BDP and Formoterol + AC Plus	Active Comparator	Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device	Drug: BDP + AC Plus Drug: Formoterol + AC Plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CHF1535 pMDI + AC Plus	Drug	Four inhalations for a total dose of BDP/FF 200/24 mcg	CHF1535 pMDI + AC Plus

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
B17MP PK profile		pre-dose until 8 hours post-dose
BDP PK prolile		Pre-dose until 8 hours post-dose
Formoterol PK profile

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Hans Bisgaard, MD DMSci	BorneAstmaKlinikken	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
BorneAstmaKlinikken		Copenhagen		2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24746942	Background	Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16.
22978252

ID	Term
D001249	Asthma
D053120	Respiratory Aspiration

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
C048053	alpha-ketoisovalerate dehydrogenase phosphatase
D001507	Beclomethasone
D000068759	Formoterol Fumarate

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids