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

Sponsored by:	Topigen Pharmaceuticals
Information provided by:	Topigen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00327808

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: TPI-1020 Drug: budesonide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Topigen Pharmaceuticals:

Primary Outcome Measures:

To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke [ Time Frame: 22 days ]

Secondary Outcome Measures:

To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22 [ Time Frame: 22 days ]
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 ]
To compare pre-dose FEV1 measurements on multiple days throughout the study [ Time Frame: 22 days ]
To compare peak flow measurements throughout the study [ Time Frame: 22 days ]
To compare the use of daily rescue medication (salbutamol) throughout the study [ Time Frame: 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 [ Time Frame: 22 days ]

Enrollment:	27
Study Start Date:	May 2006
Study Completion Date:	March 2007

Arms	Assigned Interventions
1: Experimental TPI 1020	Drug: TPI-1020 600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
2: Active Comparator Budesonide inhaler	Drug: budesonide 400 mcg BID x 14 days then 800 mcg/day x 7 more days

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327808

Locations

Canada, Ontario
McMaster University Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Kingston General Hospital
Kingston, Ontario, Canada, K7L 106
Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
CARL
Laval, Quebec, Canada, H7V 3Y7
Hopital Sacre Coeur
Montreal, Quebec, Canada, H4J 1G5
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Centre Hospitalier St-Sacrement
Ste-Foy, Quebec, Canada, G1S 4L8

Sponsors and Collaborators

Topigen Pharmaceuticals

Investigators

Study Director:

Paolo Renzi, MD

Topigen Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	TPI 1020-202
Study First Received:	May 17, 2006
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00327808 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Topigen Pharmaceuticals:

Smokers
Adults
Inflammatory markers

Study placed in the following topic categories:

Anti-Inflammatory Agents
Bronchial Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Asthma
Anti-Asthmatic Agents
Hormones
Glucocorticoids

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Hormones
Glucocorticoids

Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009