AsthmaPhase 2NCT00822861
Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma
A Phase 2 study testing TPI ASM8 in people with Asthma, run by Syntara at 1 site in Canada.
Trial summary
During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- TPI ASM8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Feb 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 18 to 65 years of age
- Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria
- History of episodic wheeze and shortness of breath
- Forced expiratory volume in one 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.
Who cannot join
- 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 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open Label, Stepwise, Dose Profiling Study to Evaluate the Efficacy and Safety of Four Dose Regimens of Inhaled TPI ASM8 in Patients With Allergic Asthma
During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.
Read the detailed description
The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.
- Conditions
- Asthma
- Being tested
- TPI ASM8
- 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
Also called ASM8
4 mg/mL, 1 mg BID for 4 days
TPI ASM8Drug
Also called ASM8
4 mg/mL, 2 mg BID for 4 days
TPI ASM8Drug
Also called ASM8
4 mg/mL, 4 mg BID for 4 days
TPI ASM8Drug
Also called ASM8
4 mg/mL, 8 mg OD for 4 days
| Study group | Role | What they receive |
|---|---|---|
| Dose level No.1 | Experimental | TPI ASM8 1 mg BID Receives: Drug: TPI ASM8 |
| Dose level No.2 | Experimental | TPI ASM8 2 mg BID Receives: Drug: TPI ASM8 |
| Dose level No.3 | Experimental | TPI ASM8 4mg BID Receives: Drug: TPI ASM8 |
| Dose level No.4 | Experimental | TPI ASM8 8 mg Die Receives: Drug: TPI ASM8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum eosinophils (%) on Day 4 versus Screening for each dose level.
Measured: 7 and 24 hrs post-allergen challenge
Secondary outcomes (2)
Safety and tolerability.
Measured: Throughout the study
Plasma and sputum pharmacokinetic profile at the two highest dose levels.
Measured: Dose level 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rene Pageau, B.Pharm M.Sc, Study director, Topigen Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822861
- Sponsor's protocol ID
- TPI ASM8-206
- Status last verified
- Nov 2013
- First submitted
- 13 Jan 2009
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Stepwise, Dose Profiling Study to Evaluate the Efficacy and Safety of Four Dose Regimens of Inhaled TPI ASM8 in Patients With Allergic Asthma
- ClinicalTrials.gov ID
- NCT00822861
- Acronym / sponsor ID
- TPI ASM8-206
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Jan 2009 (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.
During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.
Detailed description
The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose level No.1 | Experimental | Drug: TPI ASM8TPI ASM8 1 mg BID |
| Dose level No.2 | Experimental | Drug: TPI ASM8TPI ASM8 2 mg BID |
| Dose level No.3 | Experimental | Drug: TPI ASM8TPI ASM8 4mg BID |
| Dose level No.4 | Experimental | Drug: TPI ASM8TPI ASM8 8 mg Die |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women 18 to 65 years of age
- Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria
- History of episodic wheeze and shortness of breath
- Forced expiratory volume in one 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.
Key exclusion criteria (3 listed)
- 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 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).
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 ASM8Also: ASM84 mg/mL, 1 mg BID for 4 days | Drug | Dose level No.1 |
| TPI ASM8Also: ASM84 mg/mL, 2 mg BID for 4 days | Drug | Dose level No.2 |
| TPI ASM8Also: ASM84 mg/mL, 4 mg BID for 4 days | Drug | Dose level No.3 |
| TPI ASM8Also: ASM84 mg/mL, 8 mg OD for 4 days | Drug | Dose level No.4 |
Primary outcome
Sputum eosinophils (%) on Day 4 versus Screening for each dose level.
Time frame: 7 and 24 hrs post-allergen challenge
2 secondary outcomes
Safety and tolerability.
Time frame: Throughout the study
Plasma and sputum pharmacokinetic profile at the two highest dose levels.
Time frame: Dose level 3 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Rene Pageau, B.Pharm M.Sc study director
Topigen Pharmaceuticals Inc.
1 site 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 in people with Asthma, run by Syntara at 1 site 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (%) on Day 4 versus Screening for each dose level. (time frame: 7 and 24 hrs post-allergen challenge). 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 15 Nov 2013.