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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00327808
First received: May 17, 2006
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.


Condition Intervention Phase
Asthma
Drug: TPI-1020
Drug: budesonide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke [ Time Frame: 22 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22 [ Time Frame: 22 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare pre-dose FEV1 measurements on multiple days throughout the study [ Time Frame: 22 days ] [ Designated as safety issue: No ]
  • To compare peak flow measurements throughout the study [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]
  • To compare the use of daily rescue medication (salbutamol) throughout the study [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: May 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327808

Locations
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
Hopital Sacre Coeur
Montreal, Quebec, Canada, H4J 1G5
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Centre Hospitalier St-Sacrement
Ste-Foy, Quebec, Canada, G1S 4L8
Sponsors and Collaborators
Pharmaxis
Investigators
Study Director: Paolo Renzi, MD Pharmaxis
  More Information

No publications provided

Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00327808     History of Changes
Other Study ID Numbers: TPI 1020-202
Study First Received: May 17, 2006
Last Updated: November 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by Pharmaxis:
Smokers
Adults
Inflammatory markers

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 27, 2014