Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old

Asthma in Children Clinical Trial

— PAED4  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468272
• Other study ID #: CCD-1103-PR-0058
• Status: Completed
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: August 2012

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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Drug:
• free comb. beclomethasone DPI and formoterol DPI
free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug).
• CHF 1535 50/6 NEXT DPI
four inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug)

Locations

Country	Name	City	State
Denmark	BørneAstmaKlinikken, Hans Knudsens Plads 1A,	Copenhagen,

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Chawes BL, Govoni M, Kreiner-Møller 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 beclom — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	B17MP (active metabolite of BDP) Area Under Curve (AUC)	B17MP: Profile of Pharmacokinetics	predose, 15,30min, 1,2,4,6,8 hours post dose
Secondary	B17MP Cmax,Tmax,T1/2	BDP: profile of pharmacokinetics.	predose, 15min,30min,1,2,4,6,8 hours post dose
Secondary	BDP Area Under Curve (AUC), Cmax, Tmax, T1/2	BDP: profile of Pharmacokinetics	predose, 15min,30min,1,2,4,6,8 hours postdose
Secondary	Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2	Formoterol: profile of pharmacokinetics	predose, 15min, 30 min, 1,2,4,6,8 hours postdose
Secondary	plasma potassium Area Under Curve (AUC), Cmin, Tmin	plasma potassium to evaluate drug systemic effect	predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Secondary	Heart Rate: Time averaged Heart Rate value: AUC0-t/t	Heart Rate to evaluate drug systemic effect	predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Secondary	Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat).	Urinary cortisol to evaluate drug systemic effect	from predose up to 8 hours postdose

External Links

•   Study Record on EU Clinical Trials Register including results