MedTrace Logo

Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

NCT01158898 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-11-15

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.

Conditions

Interventions

DRUG

TPI ASM8

ASM8 4mg/mL (low dose) daily for 14 days by inhalation

DRUG

TPI ASM8

ASM8 4mg/mL (high dose) daily for 14 days by inhalation

DRUG

TPI ASM8

Placebo PBS solution daily for 14 days by inhalation

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Paul O'Byrne, MD · McMaster University

  • Rene Pageau, M.Sc Pharm · Pharmaxis Ltd

  • Louis-Philippe Boulet, MD · Hopital Laval, Quebec

  • Richard Leigh, MD · University of Calgary

  • Gail M Gauveau, PhD · McMaster University

  • Mark Fitzgerald, MD · Vancouver Coastal Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT01158898 on ClinicalTrials.gov