AsthmaPhase 2NCT00402948
Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients
A Phase 2 study testing TPI ASM8 and ASM8 in people with Asthma, run by Syntara at 10 sites in Canada.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- TPI ASM8 and ASM8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 10 sitesCanada
- Study dates
- Feb 2007to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Respiratory infection within last 4 weeks
- Any condition that may affect the conduct of the study as per the investigators
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Calgary COPD & Asthma Program
Calgary, Alberta, T2N 4N1
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
McMaster University Hospital
Hamilton, Ontario, L8N 3 Z5
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N 4A6
Kingston General Hospital
Kingston, Ontario, K7L: 1O6
Institut Thoracique de Montreal
Montreal, Quebec, H2X 2P4
Hopital Sacre Coeur
Montreal, Quebec, H4J 1G5
Hopital Laval- Centre de recherche de Cardiologie et Pneumologie
Québec, Quebec, G1V 4G5
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
St-Paul's Hospital
Vancouver, British Columbia, V6Z iY6
About this study
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.
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.
Read the detailed description
See above
- Conditions
- Asthma
- Being tested
- TPI ASM8, ASM8
- Keywords
- High eosinophils level in sputum
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI ASM8Drug
0.25mg, 0.5mg for 14 days, daily dosage
ASM8Drug
inhalation 0.25mg daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| TPI ASM8 | Experimental | ASM8 0.25mg Receives: Drug: TPI ASM8 |
| ASM8 as TPI ASM8 | Experimental | TPI ASM8 0.5mg Receives: Drug: ASM8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14
Measured: Prospective
Secondary outcomes (4)
FEV 1 on Day 1 and Day 14
Measured: Prospective
Rescue Medication (albuterol)for 21 days
Measured: Prospective
Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF
Measured: Prospective
Blood eosinophils at Day 0 and Day 15
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionDec 2007
Why it stopped: Lack of substantial enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Parameswaram Nair, MD, Principal investigator, Firestone Institute for Respiratory Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402948
- Sponsor's protocol ID
- TPI ASM8 -204
- Status last verified
- Nov 2012
- First submitted
- 21 Nov 2006
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00402948
- Acronym / sponsor ID
- TPI ASM8 -204
- Conditions
- Asthma
- Keywords
- High eosinophils level in sputum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of substantial enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPI ASM8 | Experimental | Drug: TPI ASM8ASM8 0.25mg |
| ASM8 as TPI ASM8 | Experimental | Drug: ASM8TPI ASM8 0.5mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Respiratory infection within last 4 weeks
- Any condition that may affect the conduct of the study as per the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPI ASM80.25mg, 0.5mg for 14 days, daily dosage | Drug | TPI ASM8 |
| ASM8inhalation 0.25mg daily for 14 days | Drug | ASM8 as TPI ASM8 |
Primary outcome
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14
Time frame: Prospective
4 secondary outcomes
FEV 1 on Day 1 and Day 14
Time frame: Prospective
Rescue Medication (albuterol)for 21 days
Time frame: Prospective
Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF
Time frame: Prospective
Blood eosinophils at Day 0 and Day 15
Time frame: Prospective
Results and safety
The study was stopped early (reason given: Lack of substantial enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parameswaram Nair, MD principal investigator
Firestone Institute for Respiratory Health
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPI ASM8 and ASM8 in people with Asthma, run by Syntara at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of substantial enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14 (time frame: Prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.