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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: TPI-1020
* Drug: budesonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaler<br>TPI 1020 | Drug: TPI-1020<br>* 600 mcg BID x 14 days followed by 1200 mcg BID x 7 days<br>|
| Active Comparator: Inhaler cortico.<br>Budesonide inhaler | Drug: budesonide<br>* 400 mcg BID x 14 days then 800 mcg/day x 7 more days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke |  | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smokers, Adults, Inflammatory markers