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

Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848769
• Other study ID #: CCD-0902-PR-0013
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF1535 pMDI + AC Plus
Four inhalations for a total dose of BDP/FF 200/24 mcg
• BDP + AC Plus
Four inhalations for a total dose of BDP 200 mcg
• Formoterol + AC Plus
Four inhalations for a total dose of Formoterol 24 mcg

Locations

Country	Name	City	State
Denmark	BorneAstmaKlinikken	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Chawes BL, Piccinno A, Kreiner-Møller E, Vissing NH, Poorisrisak P, Mortensen L, Nilson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Sergio F, Ciurlia G, Poli G, Acerbi D, Bisgaard H. Pharmacokinetic comparison of inhaled fixed combination — View Citation

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. — View Citation

Outcome

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

External Links

•   Study Record on EU Clinical Trials Register including results