A Randomised, Double-blind, Placebo-controlled, Three-way Crossover Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Two Doses of Inhaled CHF6001 DPI After 9 Days of Treatment in Adult Patients With Asthma

Chiesi Farmaceutici S.p.A.3 sites in 1 country36 target enrollmentOctober 2012

ConditionsAsthma

InterventionsPlacebo CHF6001

DrugsCHF6001 Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Asthma
Sponsor: Chiesi Farmaceutici S.p.A.
Enrollment: 36
Locations: 3
Primary Endpoint: Allergen challenge
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

April 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chiesi Farmaceutici S.p.A.

Responsible Party

Sponsor

Eligibility 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