A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics

Study Identifier:
CCD-1202-PR-0080
ClinicalTrials.gov Identifier:
NCT01689571
EudraCT Identifier:
2012-001483-29
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: CHF6001
  • Drug: Placebo
Date
Oct 2012 - Apr 2013
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • written informed consent obtained
  • Non smoking or ex-smokers from at least 1 year prior to study entry
  • Males of females between 18 and 60 years inclusive
  • Body Mass Index between 18 and 32 kg/m2
  • Ability to be trained about the proper use of the inhalation device and to perform spirometry
  • With mild to moderate allergic asthma as defined by the GINA guideline, steroid naive
  • Atopy to at least one common aeroallergen
  • Positive allergen-induced Early Asthmatic Response and Late Asthmatic Response at screening
  • Ability to produce an adequate sputum sample
  • Post-menopausal women, women of not childbearing potential or males and females of childbearing potential willing (they or their partner) to use a reliable method of contraception.
Exclusion Criteria
  • Worsening of asthma or respiratory tract infection prior to study entry
  • History of life-threatening asthma or hospitalization for asthma prior to the study entry
  • Pregnant or lactating women
  • History of clinically significant hypotensive episodes or fainting, dizziness or light-headedness
  • History or symptoms of clinically relevant neurologic disease
  • Symptomatic hay fever
  • Unstable concurrent disease that may impact the feasibility of the study
  • Use of systemic corticosteroids, nebulised bronchodilator or oral beta2-agonist
  • Use of leukotrienes modifiers, roflumilast or cromoglycate
  • Use of long acting beta2-agonist or inhaled corticosteroids
  • Use of short-acting or long-acting non-sedatives antihistamines
  • Use of any other medication for the treatment of allergic asthma other than salbutamol
  • Having received an investigational medicinal drug within 30 days prior to study entry
  • Blood drawn of at least 250 ml in the previous 45 days
  • Ongoing use of tobacco
  • Other lung disease
  • Recent history of alcohol dependency
  • Inability to comply with the study protocol
Healthy Volunteers
No

Protocol Summary

The study is designed to look at the safety, tolerability and efficacy of 2 different doses of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001 after an allergen challenge.

Study Locations

Location
Status
Location
Hammersmith Medicines Research
London, United Kingdom
Status
N/A
Location
Respiratory Clinical Trials
London, United Kingdom
Status
N/A
Location
Medicines Evaluation Unit
Manchester, United Kingdom
Status
N/A