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Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

NCT ID: NCT01158898

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TPI ASM8 low dose

Group Type ACTIVE_COMPARATOR

TPI ASM8

Intervention Type DRUG

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

TPI ASM8 high dose

Group Type ACTIVE_COMPARATOR

TPI ASM8

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

TPI ASM8

Intervention Type DRUG

Placebo PBS solution daily for 14 days by inhalation

Interventions

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TPI ASM8

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

Intervention Type DRUG

TPI ASM8

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

Intervention Type DRUG

TPI ASM8

Placebo PBS solution daily for 14 days by inhalation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mild asthma, male and female aged 18-55 y.old
* Steroid-naive, non-smoker
* Dual responders

Exclusion Criteria

* Any chronic disease(unstable)
* Immunosuppressed, recent or ongoing steroid intake
* Methacholine PC 20 \> 16 mg/mL
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syntara

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul O'Byrne, MD

Role: STUDY_CHAIR

McMaster University

Rene Pageau, M.Sc Pharm

Role: STUDY_DIRECTOR

Pharmaxis Ltd

Louis-Philippe Boulet, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Laval, Quebec

Richard Leigh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Gail M Gauveau, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Mark Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

Vancouver Coastal Health Research Institute

Locations

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Health Research Innovation Centre

Calgary, Alberta, Canada

Site Status

Vancouver Coastal Health Research Institute

Vancouver, British Columbia, Canada

Site Status

McMaster University

Hamilton, Ontario, Canada

Site Status

Laval Centre de Pneumologie Chest Division

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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TPI ASM8-207

Identifier Type: -

Identifier Source: org_study_id

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