Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Co... | NCT00402948

Studies
Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients

NCT00402948

Sponsor

Syntara

Status

Terminated

Last Update Posted

Dec 3, 2012Estimated

Enrollment

10Actual

Phase

Phase 2

Conditions

Asthma

Interventions

TPI ASM8
ASM8

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of substantial enrollment

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Nov 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Nov 21, 2006

First Submission Date that Met QC Criteria

Nov 21, 2006

First Posted Date

Nov 23, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . The study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.

Detailed Description

See above

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TPI ASM8	Experimental	ASM8 0.25mg	Drug: TPI ASM8
ASM8 as TPI ASM8	Experimental	TPI ASM8 0.5mg	Drug: ASM8

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TPI ASM8	Drug	0.25mg, 0.5mg for 14 days, daily dosage	TPI ASM8
ASM8

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14		Prospective

Secondary Outcomes

Measure	Description	Time Frame
FEV 1 on Day 1 and Day 14		Prospective
Rescue Medication (albuterol)for 21 days		Prospective
Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65 y. old, non or ex-smokers for > 6 months
Mild to moderate asthmatic in general good health
On either low-dose inhaled corticosteroid or steroid naive
No other asthma medication
Regular sputum producer
EOS more than 3% at randomization,
FEV1 > 70%

Exclusion Criteria:

Respiratory infection within last 4 weeks
Any condition that may affect the conduct of the study as per the investigators

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Parameswaram Nair, MD	Firestone Institute for Respiratory Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Calgary COPD & Asthma Program		Calgary	Alberta	T2N 4N1	Canada
University of Alberta Hospital

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C559988	TPI ASM8

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided