Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: CHF1535 pMDI + AC Plus; Drug: BDP + AC Plus; Drug: Formoterol + AC Plus

• Registration Number: NCT01848769
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-07
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHF1535 pMDI + AC Plus	CHF1535 pMDI + AC Plus	Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device
BDP and Formoterol + AC Plus	BDP + AC Plus	Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device
BDP and Formoterol + AC Plus	Formoterol + AC Plus	Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device

Primary Outcome Measures

Name	Time	Method
B17MP AUC0-t	pre-dose until 8hours post dose	B17MP (active metabolite of BDP) systemic exposure as AUC0-t

Secondary Outcome Measures

Name	Time	Method
B17MP PK profile	pre-dose until 8 hours post-dose
Formoterol PK profile	Pre-dose until 8 hours post-dose
Heart rate Time averaged heart rate value (AUC0-t)/t	Pre-dose until 8 hours post-dose	Heart rate to evaluate the drug systemic effects
Glucose in urine	Pre-dose until 8 hours post-dose	Glucose to evaluate the drug systemic effects
BDP PK prolile	Pre-dose until 8 hours post-dose
Plasma potassium AUC, Cmin, tmin	Pre-dose until 8 hours post-dose	Plasma potassium to evaluate drug systemic effect
Urinary Cortisol excretion	Pre-dose until 8 hours post-dose	8h urinary excretion of cortisol and 8h urinary excretion of cortisol normalized for 8h creatinine excretion to evaluate dru systemic effects
Spirometry: PEF	Pre-dose until 8 hours post-dose	Peak respiratory flow as a measure of drug efficacy

Trial Locations

Locations (1)

BorneAstmaKlinikken; 🇩🇰 Copenhagen, Denmark