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Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients

NCT ID: NCT00483743

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

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This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x 6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood cells and cytokines will also be studied.

Detailed Description

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A multi-centre, randomized, placebo and active-controlled, 6-week study of inhaled TPI 1020, inhaled budesonide or matching placebo (random allocation of eligible patients to the three treatments at a ratio of 3:3:1), to evaluate the safety, tolerability and pharmacodynamic activity of TPI 1020 in 42 evaluable COPD subjects.

Conditions

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Copd Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TPI 1020

TPI 1020 500 mcg BID x 42 days

Group Type EXPERIMENTAL

TPI 1020

Intervention Type DRUG

250 mcg/caps 2 caps BID x 42 days

Budosenide cortico

Budesonide 800 mcg BID x 42 days

Group Type ACTIVE_COMPARATOR

Budesonide

Intervention Type DRUG

400mcg mcg capsules- 2 capsules BID

Placebo

Placebo inhaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 caps BID x42 days

Interventions

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TPI 1020

250 mcg/caps 2 caps BID x 42 days

Intervention Type DRUG

Budesonide

400mcg mcg capsules- 2 capsules BID

Intervention Type DRUG

Placebo

2 caps BID x42 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients, male or female, smoker or ex-smoker (who quit at least a year ago) with a smoking history equal or greater than 10 pack years.
* Age between 40 and 80 years old with a diagnosis (for at least 12 months) of mild to moderate COPD

Exclusion Criteria

* COPD exacerbations indicated by a treatment with oral or systemic glucocorticosteroids and/or hospitalization and/or clinically relevant respiratory infection requiring antibiotics within 3 month of the start of the study.
* Failure to produce a sufficient sputum sample during the screening sputum induction procedure, required for TCC and differential cell count determination.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 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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Francois Maltais, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Cardiologie et de Pneumologie de l'Université Laval

Rene Pageau, M.Sc Pharm

Role: STUDY_DIRECTOR

Syntara

Locations

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University of alberta Hsopital

Edmonton, Alberta, Canada

Site Status

Vancouver Hospital Lung Center

Vancouver, British Columbia, Canada

Site Status

Firestone Institute for Respiratory Health

Hamilton, Ontario, Canada

Site Status

Clinique Medical Les Saules

Les Saules, Quebec, Canada

Site Status

Omnispec Clinical Research Inc.

Mirabel, Quebec, Canada

Site Status

Hopital Thoracique Montreal-CSUM

Montreal, Quebec, Canada

Site Status

Hopital Sacre Coeur de Montreal

Montreal, Quebec, Canada

Site Status

Kells Medical Research Group

Pointe-Claire, Quebec, Canada

Site Status

Complexe Medicale Langelier

Saint-Léonard, Quebec, Canada

Site Status

Diex Research Inc.

Sherbrooke, Quebec, Canada

Site Status

CHUS -Hopital FLEURIMONT

Sherbrooke, Quebec, Canada

Site Status

Centre de Cardiologie et de Pneumologie de l'Université Laval

Ste-Foy, Quebec, Canada

Site Status

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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TPI 1020-203

Identifier Type: -

Identifier Source: org_study_id