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Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma

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ClinicalTrials.gov Identifier: NCT00327808
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : December 3, 2012
Sponsor:
Information provided by (Responsible Party):
Pharmaxis

Study Description
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Brief Summary:
The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.

Condition or disease Intervention/treatment Phase
Asthma Drug: TPI-1020 Drug: budesonide Phase 2

Detailed Description:
This study will assess and compare the safety and tolerability of inhaled TPI 1020 versus budesonide. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will also be studied in a sub-group of subjects.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Randomized, Double-Blind, Repeated Doses Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
Study Start Date : May 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Inhaler
TPI 1020
 Drug: TPI-1020
600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
Active Comparator: Inhaler cortico.
Budesonide inhaler
 Drug: budesonide
400 mcg BID x 14 days then 800 mcg/day x 7 more days


Outcome Measures
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Primary Outcome Measures :
  1. To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke [ Time Frame: 22 days ]

Secondary Outcome Measures :
  1. To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22 [ Time Frame: 22 days ]
  2. To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14 [ Time Frame: 22 days ]
  3. To compare pre-dose FEV1 measurements on multiple days throughout the study [ Time Frame: 22 days ]
  4. To compare peak flow measurements throughout the study [ Time Frame: 22 days ]
  5. To compare the use of daily rescue medication (salbutamol) throughout the study [ Time Frame: 22 days ]
  6. To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period [ Time Frame: 22 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females 18 through 65 years of age.
  • 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 or symptoms of significant autoimmune, hematological, or neurological disease, including transient ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances that are judged clinically significant by the Investigator
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327808


Locations
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Canada, Ontario
McMaster University Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Kingston General Hospital
Kingston, Ontario, Canada, K7L 106
Canada, Quebec
CARL
Laval, Quebec, Canada, H7V 3Y7
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Hopital Sacre Coeur
Montreal, Quebec, Canada, H4J 1G5
Centre Hospitalier St-Sacrement
Ste-Foy, Quebec, Canada, G1S 4L8
Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Pharmaxis
Investigators
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Study Director: Paolo Renzi, MD Pharmaxis
More Information
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Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00327808    
Other Study ID Numbers: TPI 1020-202
First Posted: May 19, 2006    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012
Keywords provided by Pharmaxis:
Smokers
Adults
Inflammatory markers
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
 Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists