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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: CHF6001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo DPI<br>Placebo by inhalation for 9 days | Drug: Placebo<br> <br> |
| Experimental: CHF6001 DPI Dose 2<br>CHF6001 by inhalation for 9 days | Drug: CHF6001<br> <br> |
| Experimental: CHF6001 DPI Dose1<br>CHF6001 by inhalation for 9 days | Drug: CHF6001<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergen challenge |  | after 9 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induced Sputum |  | After 9 days of treatment | 
| Methacholine challenge |  | After 9 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDE4 inhibitor, Allergen Challenge, Asthma