Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old

Asthma Clinical Trial

Official title:

A Single-dose, Open-label, Randomized, 2-way Cross-over Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI in Asthmatic Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787967
• Other study ID #: CCD-01535BB1-01
• Secondary ID: 2015-005152-10
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2016
• Last updated: February 1, 2018
• Start date: August 2016
• Est. completion date: June 2017

Study information

• Verified date: February 2018
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI

Description:

This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

Inclusion Criteria:

• Male/female children with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.

• Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.

• Age = 5 < 12 years (8 to 10 children in the age range 5-8 years old).

• Children with a forced expiratory volume in one second (FEV1)>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.

• A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures

Exclusion Criteria:

• Past or present diagnosis of cardiovascular, renal or liver disease.

• Known hypersensitivity to the active treatmen

• Exacerbation of asthma symptoms within 4 weeks prior to screening.

• Inability to perform the required breathing technique and blood sampling.

• 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).

• 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:
• CHF 1535 35/4µg NEXThaler®
4 (four) inhalations (total dose: BDP/FF 140/16 µg)
• free comb. beclomethasone DPI and formoterol DPI
2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP	B17MP: Profile of Pharmacokinetics	predose, 15,30min, 1,2,4,6,8 hours post dose
Secondary	B17MP Cmax	17MP: profile of pharmacokinetics	predose, 15min,30min,1,2,4,6,8 hours post dose
Secondary	BDP Area Under Curve (AUC)	BDP: profile of Pharmacokinetics	predose, 15min,30min,1,2,4,6,8 hours post dose
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	Formoterol Cmax	Formoterol: profile of pharmacokinetics	predose, 15min, 30 min, 1,2,4,6,8 hours postdose
Secondary	Formoterol Tmax	Formoterol: profile of pharmacokinetics	predose, 15min, 30 min, 1,2,4,6,8 hours postdose
Secondary	Formoterol T1/2	Formoterol: profile of pharmacokinetics	predose, 15min, 30 min, 1,2,4,6,8 hours postdose
Secondary	plasma potassium Area Under Curve (AUC)	plasma potassium to evaluate drug systemic effect	predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Secondary	plasma potassium Cmin	plasma potassium to evaluate drug systemic effect	predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Secondary	plasma potassium Tmin	plasma potassium 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
Secondary	B17MP Tmax	BDP: profile of pharmacokinetics	predose, 15min,30min,1,2,4,6,8 hours post dose
Secondary	B17MP T1/2	BDP: profile of pharmacokinetics	predose, 15min,30min,1,2,4,6,8 hours post dose
Secondary	BDP Cmax	BDP: profile of pharmacokinetics	predose, 15min,30min,1,2,4,6,8 hours post dose
Secondary	BDP Tmax	BDP: profile of pharmacokinetics	predose, 15min,30min,1,2,4,6,8 hours post dose
Secondary	BDP T1/2	BDP: profile of pharmacokinetics	predose, 15min,30min,1,2,4,6,8 hours post dose

External Links

•   Study Record on EU Clinical Trials Register including results