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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00402948
Recruitment Status : Terminated (Lack of substantial enrollment)
First Posted : November 23, 2006
Last Update Posted : December 3, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: TPI ASM8 Drug: ASM8 Phase 2

Detailed Description:
See above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, To Evaluate And Compare The Safety, Tolerability And Efficacy Of Two Dosages Of Inhaled TPI ASM8 Administered For 14 Days In Patients With Mild to Moderate Asthma.
Study Start Date : February 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: TPI ASM8
ASM8 0.25mg
Drug: TPI ASM8
0.25mg, 0.5mg for 14 days, daily dosage

Experimental: ASM8 as TPI ASM8
TPI ASM8 0.5mg
Drug: ASM8
inhalation 0.25mg daily for 14 days

Primary Outcome Measures :
  1. Sputum eosinophils at Day 1 and Day 14 and safety on Day 14 [ Time Frame: Prospective ]

Secondary Outcome Measures :
  1. FEV 1 on Day 1 and Day 14 [ Time Frame: Prospective ]
  2. Rescue Medication (albuterol)for 21 days [ Time Frame: Prospective ]
  3. Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF [ Time Frame: Prospective ]
  4. Blood eosinophils at Day 0 and Day 15 [ Time Frame: Prospective ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00402948

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Canada, Alberta
Calgary COPD & Asthma Program
Calgary, Alberta, Canada, T2N 4N1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
St-Paul's Hospital
Vancouver, British Columbia, Canada, V6Z iY6
Canada, Ontario
McMaster University Hospital
Hamilton, Ontario, Canada, L8N 3 Z5
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada, L8N 4A6
Kingston General Hospital
Kingston, Ontario, Canada, K7L: 1O6
Canada, Quebec
Institut Thoracique de Montreal
Montreal, Quebec, Canada, H2X 2P4
Hopital Sacre Coeur
Montreal, Quebec, Canada, H4J 1G5
Hopital Laval- Centre de recherche de Cardiologie et Pneumologie
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
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Principal Investigator: Parameswaram Nair, MD Firestone Institute for Respiratory Health
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Responsible Party: Pharmaxis Identifier: NCT00402948    
Other Study ID Numbers: TPI ASM8 -204
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012
Keywords provided by Pharmaxis:
High eosinophils level in sputum
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases