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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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