PAED4: Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old

• Sponsor: Chiesi Farmaceutici S.p.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01468272
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma in Children	Drug: free comb. beclomethasone DPI and formoterol DPI; Drug: CHF 1535 50/6 NEXT DPI	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Nov 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: reference treatment Free combination of Beclomethasone dipropionate DPI and Formoterol fumarate DPI	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).
Experimental: CHF 1535 NEXT DPI CHF 1535 50/6 NEXT DPI	Drug: 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)

Outcome Measures

Primary Outcome Measures

1. B17MP (active metabolite of BDP) Area Under Curve (AUC) [predose, 15,30min, 1,2,4,6,8 hours post dose]

   B17MP: Profile of Pharmacokinetics

Secondary Outcome Measures

1. B17MP Cmax,Tmax,T1/2 [predose, 15min,30min,1,2,4,6,8 hours post dose]

   BDP: profile of pharmacokinetics.

2. BDP Area Under Curve (AUC), Cmax, Tmax, T1/2 [predose, 15min,30min,1,2,4,6,8 hours postdose]

   BDP: profile of Pharmacokinetics

3. Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 [predose, 15min, 30 min, 1,2,4,6,8 hours postdose]

   Formoterol: profile of pharmacokinetics

4. plasma potassium Area Under Curve (AUC), Cmin, Tmin [predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose]

   plasma potassium to evaluate drug systemic effect

5. Heart Rate: Time averaged Heart Rate value: AUC0-t/t [predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose]

   Heart Rate to evaluate drug systemic effect

6. Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat). [from predose up to 8 hours postdose]

   Urinary cortisol to evaluate drug systemic effect

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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. Lower respiratory tract infection within 1 month prior to screening (visit 1)

2. Disease (other than asthma) which might influence the outcome of the study

3. Obesity, i.e. > 97% weight percentile by local standards

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BørneAstmaKlinikken, Hans Knudsens Plads 1A,	Copenhagen,		Denmark	2100

Sponsors and Collaborators

• Chiesi Farmaceutici S.p.A.

Investigators

• Principal Investigator: Hans Bisgaard, BorneAstmaKlinikken, Copenaghen, Denmark

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Study Record on EU Clinical Trials Register including results

Publications

None provided.

• Responsible Party: Chiesi Farmaceutici S.p.A.
• ClinicalTrials.gov Identifier: NCT01468272
• Other Study ID Numbers: CCD-1103-PR-0058
• First Posted: Nov 9, 2011
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Chiesi Farmaceutici S.p.A.: asthma children NEXT DPI LABA ICS inhalation
• Additional relevant MeSH terms: Asthma; Beclomethasone; Formoterol Fumarate

Study Results

No Results Posted as of Jul 31, 2020