Multiple Dose ASM8 in Mild Asthmatics

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00264966
First received: December 12, 2005
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Asthma
Drug: ASM8
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controled, Crossover Study To Evaluate the Efficacy, Safety and Tolerability of Inhaled ASM8-003 in Subjects With Mild Allergic Asthma.

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

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

Secondary Outcome Measures:
  • 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.
  • Determination of the pharmacodynamic activity of ASM8 on specific gene expression, protein levels, differential cell counts, and eosinophilic cationic protein (ECP), as measured in sputum samples.
  • Relief medication use in the ASM8 versus placebo

Estimated Enrollment: 15
Study Start Date: December 2005
Study Completion Date: April 2006
Detailed Description:

This is a double-blind, placebo-controlled, crossover trial to evaluate the safety, tolerability and efficacy of inhaled ASM8 for the treatment of allergen-induced asthma. Individuals with stable, mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a history of episodic wheeze and shortness of breath, will be eligible for enrolment. The study is divided into 2 parts.

  Eligibility

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264966

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Saskatoon Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Pharmaxis
Investigators
Principal Investigator: Paul O'Byrne, MD McMaster University
  More Information

No publications provided by Pharmaxis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00264966     History of Changes
Other Study ID Numbers: ASM8-003
Study First Received: December 12, 2005
Last Updated: November 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by Pharmaxis:
Mild asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014