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

Study Identifier:
CCD-01535BB1-01
ClinicalTrials.gov Identifier:
NCT02787967
EudraCT Identifier:
2015-005152-10
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: CHF 1535 35/4µg NEXThaler®
  • Drug: free comb. beclomethasone DPI and formoterol DPI
Date
Aug 2016 - Jun 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 5 - 11 Years
Requirements Information
Inclusion and Exclusion 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
Healthy Volunteers
No

Protocol 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

Study Locations

Location
Status
Location
BørneAstmaKlinikken, Hans Knudsens Plads 1A,
Copenhagen, Denmark
Status
N/A