Clinical trial NCT01468272: Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old
Official title: A Single-dose,Open-label,Randomized,2-way Cross-over,Clinical Pharmacology Study of CHF1535 50/6 NEXT DPI® Fixed Combination of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6µg)Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma in Children
Keywords: asthma children NEXT DPI LABA ICS inhalation
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 26
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: This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.

Detailed description: Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the NEXT DPI dry powder inhaler or a free combination of Beclomethasone 100 ug DPI and Formoterol 6 ug DPI according to a cross-over design.

Eligibility criteria: Inclusion Criteria:

1. Male/Female children aged 5 -11y
2. Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
3. Children with stable asthma
4. Children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
5. Forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding beta2-agonists treatment for a minimum of 4 h prior to each study treatment.
6. A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures.

Exclusion Criteria:

1. Past or present diagnoses of cardiovascular, renal or liver disease
2. Known hypersensitivity to the active treatments
3. Exacerbation of asthma symptoms within the previous 4 weeks
4. Inability to perform the required breathing technique and blood sampling
5. Hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1)
6. Lower respiratory tract infection within 1 month prior to screening (visit 1)
7. Disease (other than asthma) which might influence the outcome of the study
8. Obesity, i.e. \> 97% weight percentile by local standards

Primary outcomes:
measure: B17MP (active metabolite of BDP) Area Under Curve (AUC)
timeFrame: predose, 15,30min, 1,2,4,6,8 hours post dose
Secondary outcomes:
measure: B17MP Cmax,Tmax,T1/2
timeFrame: predose, 15min,30min,1,2,4,6,8 hours post dose
measure: BDP Area Under Curve (AUC), Cmax, Tmax, T1/2
timeFrame: predose, 15min,30min,1,2,4,6,8 hours postdose
measure: Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2
timeFrame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
measure: plasma potassium Area Under Curve (AUC), Cmin, Tmin
timeFrame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
measure: Heart Rate: Time averaged Heart Rate value: AUC0-t/t
timeFrame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
measure: Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat).
timeFrame: from predose up to 8 hours postdose
Other outcomes:
Locations:
city: Copenhagen,
country: Denmark
facility: BørneAstmaKlinikken, Hans Knudsens Plads 1A,
Study officials:
affiliation: BorneAstmaKlinikken, Copenaghen, Denmark
name: Hans Bisgaard
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chawes BL, Govoni M, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilsson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Piccinno A, Sergio F, Ciurlia G, Poli G, Acerbi D, Singh D, Bisgaard H. Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent. Respir Med. 2014 Aug;108(8):1108-16. doi: 10.1016/j.rmed.2014.05.007. Epub 2014 Jun 17.