NCT00264966

Brief Summary

To determine the safety and efficacy of multiple doses of ASM8 antisense oligonucleotides in asthmatics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 asthma

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_1 asthma

Geographic Reach
1 country

3 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

December 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

First QC Date

December 12, 2005

Last Update Submit

November 30, 2012

Conditions

Asthma

Keywords

Mild asthma

Outcome Measures

Primary Outcomes (1)

  • Comparison of the allergen-induced late asthmatic response (LAR) between ASM8 and placebo

Secondary Outcomes (7)

  • Evaluation of the safety and tolerability of ASM8.

  • Comparison of the allergen-induced early asthmatic response (EAR) between ASM8 and placebo.

  • Comparison of the allergen-induced airway hyperresponsiveness between ASM8 and placebo.

  • Comparison of the allergen-induced changes in sputum eosinophils at 7 and 24 hours post allergen, between the ASM8 and placebo.

  • Determination of the plasma and sputum pharmacokinetic profile of single- and repeated-doses of ASM8 in patients with mild asthma.

  • +2 more secondary outcomes

Interventions

ASM8DRUG

Eligibility Criteria

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

You may qualify if:

  • Part 1: Men and women 18 to 65 years of age; generally good health; mild to moderate, stable, allergic asthma as defined by ATS criteria (1); history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (FEV1) at baseline ≥70% of the predicted value; able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.
  • Part 2: Methacholine challenge at baseline (PC20 ≤16 mg/mL); positive skin-prick test to common aeroallergens (cat, dust mite, grass, pollen) and positive allergen-induced early and late airway bronchoconstriction.

You may not qualify if:

  • Part 1 and Part 2: Significant acute or chronic medical or psychiatric illness; known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks; use of inhaled or oral corticosteroids within the last 28 days, antihistamines, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed); use of medications that may interact with ASM8; investigational drug use within 30 days; any clinically significant abnormality on screening laboratory determinations; current tobacco use in previous 3 months or 10 pack-years; pregnant or lactating women; women actively seeking pregnancy or who are not using adequate contraception; history of serious adverse effect (SAE) or hypersensitivity to any drug; 20% decrease in FEV1 or FVC with baseline saline in methacholine challenge during screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Saskatoon Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

  • Gauvreau GM, Boulet LP, Cockcroft DW, Baatjes A, Cote J, Deschesnes F, Davis B, Strinich T, Howie K, Duong M, Watson RM, Renzi PM, O'Byrne PM. Antisense therapy against CCR3 and the common beta chain attenuates allergen-induced eosinophilic responses. Am J Respir Crit Care Med. 2008 May 1;177(9):952-8. doi: 10.1164/rccm.200708-1251OC. Epub 2008 Jan 31.

    PMID: 18244953DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Paul O'Byrne, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 13, 2005

Study Start

December 1, 2005

Study Completion

April 1, 2006

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

CA(3)