Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old (PAED1)

Chiesi

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: CHF1535 pMDI + AC Plus; Drug: BDP + AC Plus; Drug: Formoterol + AC Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01848769

CCD-0902-PR-0013

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

CHF1535 pMDI + AC Plus

Experimental group

Description:

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

Treatment:

Drug: CHF1535 pMDI + AC Plus

BDP and Formoterol + AC Plus

Active Comparator group

Description:

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

Treatment:

Drug: Formoterol + AC Plus

Drug: BDP + AC Plus