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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-30

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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo DPI

Placebo by inhalation for 9 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

CHF6001 DPI Dose 2

CHF6001 by inhalation for 9 days

Group Type EXPERIMENTAL

CHF6001

Intervention Type DRUG

CHF6001 DPI Dose1

CHF6001 by inhalation for 9 days

Group Type EXPERIMENTAL

CHF6001

Intervention Type DRUG

Interventions

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CHF6001

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No