A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics (CHF6001_POC2)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: CHF6001

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Hammersmith Medicines Research
  • London, United Kingdom
    • Respiratory Clinical Trials
  • Manchester, United Kingdom
    • Medicines Evaluation Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo DPI; Placebo by inhalation for 9 days	Drug: Placebo
Experimental: CHF6001 DPI Dose 2; CHF6001 by inhalation for 9 days	Drug: CHF6001
Experimental: CHF6001 DPI Dose1; CHF6001 by inhalation for 9 days	Drug: CHF6001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Allergen challenge	after 9 days of treatment

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of CHF6001 and its metabolites	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	after 9 days of treatment
Vital signs		After single dose and 9 days of treatment
ECG		After single dose and 9 days of treatment

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Elizabeth Tranter, MD, Hammersmith Medicines Research

Publications and helpful links

Helpful Links

• Study Record on EU Clinical Trials Register including results

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Asthma; Allergen Challenge; PDE4 inhibitor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CCD-1202-PR-0080; 2012-001483-29 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No