Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients

NCT ID: NCT00402948

Last Updated: 2012-12-03

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-12-31

Brief Summary

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This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . The study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.

Detailed Description

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See above

Conditions

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Asthma

Keywords

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High eosinophils level in sputum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TPI ASM8

ASM8 0.25mg

Group Type EXPERIMENTAL

TPI ASM8

Intervention Type DRUG

0.25mg, 0.5mg for 14 days, daily dosage

ASM8 as TPI ASM8

TPI ASM8 0.5mg

Group Type EXPERIMENTAL

ASM8

Intervention Type DRUG

inhalation 0.25mg daily for 14 days

Interventions

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TPI ASM8

0.25mg, 0.5mg for 14 days, daily dosage

Intervention Type DRUG

ASM8

inhalation 0.25mg daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-65 y. old, non or ex-smokers for \> 6 months
* Mild to moderate asthmatic in general good health
* On either low-dose inhaled corticosteroid or steroid naive
* No other asthma medication
* Regular sputum producer
* EOS more than 3% at randomization,
* FEV1 \> 70%

Exclusion Criteria

* Respiratory infection within last 4 weeks
* Any condition that may affect the conduct of the study as per the investigators
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Parameswaram Nair, MD

Role: PRINCIPAL_INVESTIGATOR

Firestone Institute for Respiratory Health

Locations

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Calgary COPD & Asthma Program

Calgary, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

Site Status

St-Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

McMaster University Hospital

Hamilton, Ontario, Canada

Site Status

Firestone Institute for Respiratory Health

Hamilton, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Institut Thoracique de Montreal

Montreal, Quebec, Canada

Site Status

Hopital Sacre Coeur

Montreal, Quebec, Canada

Site Status

Hopital Laval- Centre de recherche de Cardiologie et Pneumologie

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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TPI ASM8 -204

Identifier Type: -

Identifier Source: org_study_id