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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01689571

Acronym

CHF6001_POC2

Enrollment

Registered

2012-09-21

Start date

2012-10-31

Completion date

2013-04-30

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

PDE4 inhibitor, Allergen Challenge, Asthma

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.

Interventions

DRUGCHF6001

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Allergen challenge	after 9 days of treatment

Secondary

Measure	Time frame
Induced Sputum	After 9 days of treatment
Methacholine challenge	After 9 days of treatment

Other

Measure	Time frame	Description
Pharmacokinetics of CHF6001 and its metabolites	after 9 days of treatment	The following parameters will be evaluated at the steady state: AUC0-t, AUC0-24h, Cmax, Cmin, Cav, tmax, tmin, t½, CL/F and Vz/F
Vital signs	After single dose and 9 days of treatment	—
ECG	After single dose and 9 days of treatment	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026