NCT00327808CompletedPhase 2
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
Syntara7 sites in 1 country27 target enrollmentStarted: May 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 7
- Primary Endpoint
- To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Inhaler
Experimental
TPI 1020
Intervention: TPI-1020 (Drug)
Inhaler cortico.
Active Comparator
Budesonide inhaler
Intervention: budesonide (Drug)
Outcomes
Primary Outcomes
To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
Time Frame: 22 days
Secondary Outcomes
- To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22(22 days)
- To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14(22 days)
- To compare pre-dose FEV1 measurements on multiple days throughout the study(22 days)
- To compare peak flow measurements throughout the study(22 days)
- To compare the use of daily rescue medication (salbutamol) throughout the study(22 days)
- 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)
Investigators
Study Sites (7)
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