|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00402948 |
|
Date of registration:
|
21/11/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients
|
|
Scientific 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. |
|
Date of first enrolment:
|
February 2007 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00402948 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Parameswaram Nair, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Firestone Institute for Respiratory Health |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Asthma
|
|
Intervention(s)
|
|
Drug: ASM8
|
|
Drug: TPI ASM8
|
|
Primary Outcome(s)
|
|
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14
[Time Frame: Prospective]
|
|
Secondary Outcome(s)
|
|
Blood eosinophils at Day 0 and Day 15
[Time Frame: Prospective]
|
|
FEV 1 on Day 1 and Day 14
[Time Frame: Prospective]
|
|
Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF
[Time Frame: Prospective]
|
|
Rescue Medication (albuterol)for 21 days
[Time Frame: Prospective]
|
|
Secondary ID(s)
|
|
TPI ASM8 -204
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|