NCT01689571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

September 4, 2012

Last Update Submit

March 28, 2017

Conditions

Asthma

Keywords

PDE4 inhibitorAllergen ChallengeAsthma

Outcome Measures

Primary Outcomes (1)

  • Allergen challenge

    after 9 days of treatment

Secondary Outcomes (2)

  • Induced Sputum

    After 9 days of treatment

  • Methacholine challenge

    After 9 days of treatment

Other Outcomes (3)

  • Pharmacokinetics of CHF6001 and its metabolites

    after 9 days of treatment

  • Vital signs

    After single dose and 9 days of treatment

  • ECG

    After single dose and 9 days of treatment

Study Arms (3)

Placebo DPI

PLACEBO COMPARATOR

Placebo by inhalation for 9 days

Drug: Placebo

CHF6001 DPI Dose 2

EXPERIMENTAL

CHF6001 by inhalation for 9 days

Drug: CHF6001

CHF6001 DPI Dose1

EXPERIMENTAL

CHF6001 by inhalation for 9 days

Drug: CHF6001

Interventions

CHF6001DRUG
CHF6001 DPI Dose 2CHF6001 DPI Dose1
PlaceboDRUG
Placebo DPI

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hammersmith Medicines Research

London, United Kingdom

Location

Respiratory Clinical Trials

London, United Kingdom

Location

Medicines Evaluation Unit

Manchester, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

tanimilast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Dave Singh, MD

    Medicines Evaluation Unit

    PRINCIPAL INVESTIGATOR

  • Brian Leaker, MD

    Respiratory Clinical Trials

    PRINCIPAL INVESTIGATOR

  • Elizabeth Tranter, MD

    Hammersmith Medicines Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 21, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

GB(3)