Clinical trial NCT00327808: Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Smokers
Adults
Inflammatory markers
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2006-05-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
timeFrame: 22 days
Secondary outcomes:
measure: To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22
timeFrame: 22 days
measure: To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14
timeFrame: 22 days
measure: To compare pre-dose FEV1 measurements on multiple days throughout the study
timeFrame: 22 days
measure: To compare peak flow measurements throughout the study
timeFrame: 22 days
measure: To compare the use of daily rescue medication (salbutamol) throughout the study
timeFrame: 22 days
measure: To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period
timeFrame: 22 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Laval
country: Canada
facility: CARL
state: Quebec
city: Montreal
country: Canada
facility: Montreal Chest Institute
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sacre Coeur
state: Quebec
city: Ste-Foy
country: Canada
facility: Centre Hospitalier St-Sacrement
state: Quebec
city: Ste-Foy
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval
state: Quebec
Study officials:
affiliation: Syntara
name: Paolo Renzi, MD
role: STUDY_DIRECTOR
References: