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

NCT01689571 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-03-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CHF6001

DRUG

Placebo

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dave Singh, MD · Medicines Evaluation Unit

  • Brian Leaker, MD · Respiratory Clinical Trials

  • Elizabeth Tranter, MD · Hammersmith Medicines Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01689571 on ClinicalTrials.gov