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Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma

NCT00550797 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-11-20

No results posted yet for this study

Summary

The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.

Conditions

  • Allergic Asthma

Interventions

BIOLOGICAL

TPI ASM8

Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each

BIOLOGICAL

placebo

Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each

Sponsors & Collaborators

  • i3 Research

    collaborator INDUSTRY

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Brian O'Connor, MD · Kings College Hospital, London, United Kingdom

  • Rene Pageau, M.Sc.Pharm · Topigen Pharmaceuticals, Montreal, Quebec/Canada

  • Pierluigi Paggiaro, Prof · University of Pisa, Pisa, Italy

  • Dave Singh, MD · Evaluation Unit, Manchester, UK

  • Peter J. Sterk, MD · University of Amsterdam, Amsterdam, The Netherlands

  • Piero Maestrelli, Prof. · University of Padova, Padova, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-07-31
Completion
2008-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00550797 on ClinicalTrials.gov