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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

May 17, 2006
November 30, 2012
May 2006
March 2007   (final data collection date for primary outcome measure)
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 ]
To determine the safety and tolerability of multiple doses of TPI 1020 in subjects with asthma who smoke.
Complete list of historical versions of study NCT00327808 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To compare sputum neutrophil and eosinophil counts on Day 0 vs. Day 15 and Day 22
  • To determine pharmacodynamic effects on FEV1 over 8 hours on Day 1 and Day 14
  • To compare pre-dose FEV1 measurements on multiple days throughout the study
  • To compare peak flow measurements throughout the study
  • To compare the use of daily rescue medication (salbutamol) throughout the study
  • To determine the plasma PK profile on a sub-group of subjects on first and last day of the dosing period. .
Not Provided
Not Provided
 
Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: TPI-1020
    600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
  • Drug: budesonide
    400 mcg BID x 14 days then 800 mcg/day x 7 more days
  • Experimental: Inhaler
    TPI 1020
    Intervention: Drug: TPI-1020
  • Active Comparator: Inhaler cortico.
    Budesonide inhaler
    Intervention: Drug: budesonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00327808
TPI 1020-202
No
Pharmaxis
Pharmaxis
Not Provided
Study Director: Paolo Renzi, MD Pharmaxis
Pharmaxis
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP