Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
NCT ID: NCT00327808
Last Updated: 2012-12-03
Study Results
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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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2006-05-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Inhaler
TPI 1020
TPI-1020
600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
Inhaler cortico.
Budesonide inhaler
budesonide
400 mcg BID x 14 days then 800 mcg/day x 7 more days
Interventions
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TPI-1020
600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
budesonide
400 mcg BID x 14 days then 800 mcg/day x 7 more days
Eligibility Criteria
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Inclusion Criteria
* Smoking history of more than 5 pack/years but less than 25 pack/years and who have no desire to quit smoking despite physician's advice and who currently smoke at least 5 cigarettes per day.
* Mild to moderate, stable, allergic asthma as defined by American Thoracic Society (ATS) criteria 1
* History of episodic wheeze and shortness of breath
* Subjects currently and only receiving inhaled short-acting bronchodilator treatment for asthma.
Exclusion Criteria
* History of serious adverse reaction or hypersensitivity to corticosteroids
* Abnormal chest X-ray that is judged clinically significant
* Pregnant or lactating or have positive plasma pregnancy test
* Use of oral/parenteral/inhaled corticosteroids within the last 28 days or injectable depot corticosteroids within the last 6 weeks.
* Use of any other asthma-related medications within 1 month of Screening
18 Years
65 Years
ALL
No
Sponsors
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Syntara
INDUSTRY
Responsible Party
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Principal Investigators
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Paolo Renzi, MD
Role: STUDY_DIRECTOR
Syntara
Locations
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McMaster University Hospital
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
CARL
Laval, Quebec, Canada
Montreal Chest Institute
Montreal, Quebec, Canada
Hopital Sacre Coeur
Montreal, Quebec, Canada
Centre Hospitalier St-Sacrement
Ste-Foy, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval
Ste-Foy, Quebec, Canada
Countries
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Other Identifiers
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TPI 1020-202
Identifier Type: -
Identifier Source: org_study_id