NCT00327808

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started May 2006

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

10 months

First QC Date

May 17, 2006

Last Update Submit

November 30, 2012

Conditions

Asthma

Keywords

SmokersAdultsInflammatory markers

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke

    22 days

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Inhaler

EXPERIMENTAL

TPI 1020

Drug: TPI-1020

Inhaler cortico.

ACTIVE COMPARATOR

Budesonide inhaler

Drug: budesonide

Interventions

TPI-1020DRUG

600 mcg BID x 14 days followed by 1200 mcg BID x 7 days

Inhaler
budesonideDRUG

400 mcg BID x 14 days then 800 mcg/day x 7 more days

Inhaler cortico.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

McMaster University Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 106, Canada

Location

CARL

Laval, Quebec, H7V 3Y7, Canada

Location

Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

Hopital Sacre Coeur

Montreal, Quebec, H4J 1G5, Canada

Location

Centre Hospitalier St-Sacrement

Ste-Foy, Quebec, G1S 4L8, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

NCX 1020Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Paolo Renzi, MD

    Syntara

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 19, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

CA(7)