Overview

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

Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Treatments:
Beclomethasone
Formoterol Fumarate
Criteria
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