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

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Chiesi

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Drug: Placebo
Drug: CHF6001

Study type

Interventional

Funder types

Industry

Identifiers

NCT01689571
CCD-1202-PR-0080
2012-001483-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

36 participants in 3 patient groups, including a placebo group

Placebo DPI
Placebo Comparator group
Description:
Placebo by inhalation for 9 days
Treatment:
Drug: Placebo
CHF6001 DPI Dose 2
Experimental group
Description:
CHF6001 by inhalation for 9 days
Treatment:
Drug: CHF6001
CHF6001 DPI Dose1
Experimental group
Description:
CHF6001 by inhalation for 9 days
Treatment:
Drug: CHF6001

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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