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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327808
• Other study ID #: TPI 1020-202
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2006
• Last updated: November 30, 2012
• Start date: May 2006
• Est. completion date: March 2007

Study information

• Verified date: November 2012
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	McMaster University Hospital	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	CARL	Laval	Quebec
Canada	Hopital Sacre Coeur	Montreal	Quebec
Canada	Montreal Chest Institute	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

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke		22 days	No
Secondary	To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22		22 days	No
Secondary	To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14		22 days	No
Secondary	To compare pre-dose FEV1 measurements on multiple days throughout the study		22 days	No
Secondary	To compare peak flow measurements throughout the study		22 days	Yes
Secondary	To compare the use of daily rescue medication (salbutamol) throughout the study		22 days	Yes
Secondary	To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period		22 days	No