Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics
