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

Asthma Clinical Trial

— CHF6001_POC2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689571
• Other study ID #: CCD-1202-PR-0080
• Secondary ID: 2012-001483-29
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2012
• Last updated: March 28, 2017
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF6001

• Placebo

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London
United Kingdom	Respiratory Clinical Trials	London
United Kingdom	Medicines Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Vital signs		After single dose and 9 days of treatment
Other	ECG		After single dose and 9 days of treatment
Primary	Allergen challenge		after 9 days of treatment
Secondary	Induced Sputum		After 9 days of treatment
Secondary	Methacholine challenge		After 9 days of treatment

External Links

•   Study Record on EU Clinical Trials Register including results