Efficacy/Safety Study of Nebulized IVX-0142, a Novel Anti... | NCT00232999

Studies
Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma

NCT00232999

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Status

Completed

Last Update Posted

Nov 12, 2021Actual

Enrollment

15Actual

Phase

Phase 2

Conditions

Asthma

Interventions

Nebulized IVX-0142

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 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Dec 2005Actual

Completion Date

Jan 2006Actual

First Submitted Date

Oct 4, 2005

First Submission Date that Met QC Criteria

Oct 4, 2005

First Posted Date

Oct 5, 2005Estimated

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 5, 2021

Last Update Posted Date

Nov 12, 2021Actual

Name	Class
AllerGen NCE Inc.	INDUSTRY

Description Module

Brief Summary

This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.

Detailed Description

Not provided

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

15Actual

Name	Type	Description	Arm Group Labels	Other Names
Nebulized IVX-0142	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions

Secondary Outcomes

Measure	Description	Time Frame
Methacholine PC20 pre- and post-allergen challenge
Anti-inflammatory activity in airways

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild stable allergic asthma
Positive skin-prick test to at least one common aeroallergen
Positive methacholine challenge
Positive allergen-induced early- and late-phase airway bronchoconstriction
General good health

Exclusion Criteria:

Lung diseases other than mild allergic asthma
History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease
Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium
Use of tobacco products within one year starting study or smoking history >10 pack years
If female, pregnant or lactating or have positive pregnancy test at screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul M O'Byrne, MD	McMaster University and AllerGen NCE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, McMaster University		Hamilton	Ontario	L8N 3Z5	Canada
Centre de cardiology et de pneumologie de l'Universite Laval

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18699936	Result	Duong M, Cockcroft D, Boulet LP, Ahmed T, Iverson H, Atkinson DC, Stahl EG, Watson R, Davis B, Milot J, Gauvreau GM, O'Byrne PM. The effect of IVX-0142, a heparin-derived hypersulfated disaccharide, on the allergic airway responses in asthma. Allergy. 2008 Sep;63(9):1195-201. doi: 10.1111/j.1398-9995.2008.01707.x.

ID	Term
D001249	Asthma
D016535	Bronchial Hyperreactivity

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