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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NEXThaler® 35/4µg

CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations. Total Dose: BDP 200µg FF 16µg

Group Type EXPERIMENTAL

CHF 1535 35/4µg NEXThaler®

Intervention Type DRUG

4 (four) inhalations (total dose: BDP/FF 140/16 µg)

Reference treatment

Drug: 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

Group Type ACTIVE_COMPARATOR

free comb. beclomethasone DPI and formoterol DPI

Intervention Type DRUG

2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg

Interventions

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CHF 1535 35/4µg NEXThaler®

4 (four) inhalations (total dose: BDP/FF 140/16 µg)

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No