Clinical trial NCT01848769: Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
ICS+LABA
Children
Inhalation
pMDI
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: B17MP AUC0-t
timeFrame: pre-dose until 8hours post dose
Secondary outcomes:
measure: B17MP PK profile
timeFrame: pre-dose until 8 hours post-dose
measure: BDP PK prolile
timeFrame: Pre-dose until 8 hours post-dose
measure: Formoterol PK profile
timeFrame: Pre-dose until 8 hours post-dose
measure: Plasma potassium AUC, Cmin, tmin
timeFrame: Pre-dose until 8 hours post-dose
measure: Urinary Cortisol excretion
timeFrame: Pre-dose until 8 hours post-dose
measure: Glucose in urine
timeFrame: Pre-dose until 8 hours post-dose
measure: Heart rate Time averaged heart rate value (AUC0-t)/t
timeFrame: Pre-dose until 8 hours post-dose
measure: Spirometry: PEF
timeFrame: Pre-dose until 8 hours post-dose
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: BorneAstmaKlinikken
Study officials:
affiliation: BorneAstmaKlinikken
name: Hans Bisgaard, MD DMSci
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Chawes BL, Piccinno A, Kreiner-Moller 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 vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children. Br J Clin Pharmacol. 2013 Apr;75(4):1081-8. doi: 10.1111/j.1365-2125.2012.04459.x.