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Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma

NCT ID: NCT00822861

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-02-28

Brief Summary

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During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.

Detailed Description

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The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose level No.1

TPI ASM8 1 mg BID

Group Type EXPERIMENTAL

TPI ASM8

Intervention Type DRUG

4 mg/mL, 1 mg BID for 4 days

Dose level No.2

TPI ASM8 2 mg BID

Group Type EXPERIMENTAL

TPI ASM8

Intervention Type DRUG

4 mg/mL, 2 mg BID for 4 days

Dose level No.3

TPI ASM8 4mg BID

Group Type EXPERIMENTAL

TPI ASM8

Intervention Type DRUG

4 mg/mL, 4 mg BID for 4 days

Dose level No.4

TPI ASM8 8 mg Die

Group Type EXPERIMENTAL

TPI ASM8

Intervention Type DRUG

4 mg/mL, 8 mg OD for 4 days

Interventions

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TPI ASM8

4 mg/mL, 1 mg BID for 4 days

Intervention Type DRUG

TPI ASM8

4 mg/mL, 2 mg BID for 4 days

Intervention Type DRUG

TPI ASM8

4 mg/mL, 4 mg BID for 4 days

Intervention Type DRUG

TPI ASM8

4 mg/mL, 8 mg OD for 4 days

Intervention Type DRUG

Other Intervention Names

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ASM8 ASM8 ASM8 ASM8

Eligibility Criteria

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Inclusion Criteria

* Men and women 18 to 65 years of age
* Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria
* History of episodic wheeze and shortness of breath
* Forced expiratory volume in one second (FEV1) at baseline ≥ 70% of the predicted value
* Able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.

Exclusion Criteria

* Significant acute or chronic medical or psychiatric illness
* Known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks
* Use of inhaled or oral corticosteroids within the last 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Rene Pageau, B.Pharm M.Sc

Role: STUDY_DIRECTOR

Topigen Pharmaceuticals Inc.

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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TPI ASM8-206

Identifier Type: -

Identifier Source: org_study_id