Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic 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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).

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Detailed Description

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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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CHF1535 pMDI + AC Plus

Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device

Group Type EXPERIMENTAL

CHF1535 pMDI + AC Plus

Intervention Type DRUG

Four inhalations for a total dose of BDP/FF 200/24 mcg

BDP and Formoterol + AC Plus

Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device

Group Type ACTIVE_COMPARATOR

BDP + AC Plus

Intervention Type DRUG

Four inhalations for a total dose of BDP 200 mcg

Formoterol + AC Plus

Intervention Type DRUG

Four inhalations for a total dose of Formoterol 24 mcg

Interventions

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CHF1535 pMDI + AC Plus

Four inhalations for a total dose of BDP/FF 200/24 mcg

Intervention Type DRUG

BDP + AC Plus

Four inhalations for a total dose of BDP 200 mcg

Intervention Type DRUG

Formoterol + AC Plus

Four inhalations for a total dose of Formoterol 24 mcg

Intervention Type DRUG

Other Intervention Names

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Fixed combination of BDP and FF 50/6 mcg Beclomethasone Dipropionate 50 mcg with Aerochamber Plus Formoterol 6 mcg with Aerochamebr Plus

Eligibility Criteria

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Inclusion Criteria

* Male/Female children aged 5-11 years
* Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
* children with stable asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
* Forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period.

6\. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.

Exclusion Criteria

* Past or present diagnoses of cardiovascular, renal or liver disease
* Known hypersensitivity to the active treatments
* Exacerbation of asthma symptoms within the previous 4 weeks
* Inability to perform the required breathing technique and blood sampling
* Hospitalization due to exacerbation of asthma within 1 month prior to inclusion
* Lower respiratory tract infection within 1 month prior to inclusion
* 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