Clinical trial NCT01689571: A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: PDE4 inhibitor
Allergen Challenge
Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Allergen challenge
timeFrame: after 9 days of treatment
Secondary outcomes:
measure: Induced Sputum
timeFrame: After 9 days of treatment
measure: Methacholine challenge
timeFrame: After 9 days of treatment
Other outcomes:
measure: Pharmacokinetics of CHF6001 and its metabolites
timeFrame: after 9 days of treatment
measure: Vital signs
timeFrame: After single dose and 9 days of treatment
measure: ECG
timeFrame: After single dose and 9 days of treatment
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
city: London
country: United Kingdom
facility: Respiratory Clinical Trials
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: Medicines Evaluation Unit
name: Dave Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Respiratory Clinical Trials
name: Brian Leaker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hammersmith Medicines Research
name: Elizabeth Tranter, MD
role: PRINCIPAL_INVESTIGATOR
References: