AsthmaPhase 2NCT01158898
Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
A Phase 2 study testing TPI ASM8 in people with Asthma, run by Syntara at 4 sites in Canada.
Trial summary
This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- TPI ASM8
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 4 sitesCanada
- Study dates
- Nov 2010to Feb 2012
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild asthma, male and female aged 18-55 y.old
- Steroid-naive, non-smoker
- Dual responders
Who cannot join
- Any chronic disease(unstable)
- Immunosuppressed, recent or ongoing steroid intake
- Methacholine PC 20 > 16 mg/mL
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Health Research Innovation Centre
Calgary, Alberta, T2N 4N1
McMaster University
Hamilton, Ontario, L8N 3Z5
Laval Centre de Pneumologie Chest Division
Québec, Quebec, G1V4G5
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: A Double-Blind,Randomized, Placebo-controlled, 3-Way Cross Over Study to Evaluate the Efficacy and Safety of 14 Days TPI ASM8 in Subjects With Asthma
This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.
Read the detailed description
Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.
- Conditions
- Asthma
- Being tested
- TPI ASM8
- Keywords
- Mild to moderate asthma, Allergen inhalation challenge
- 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
ASM8 4mg/mL (low dose) daily for 14 days by inhalation
TPI ASM8Drug
ASM8 4mg/mL (high dose) daily for 14 days by inhalation
TPI ASM8Drug
Placebo PBS solution daily for 14 days by inhalation
| Study group | Role | What they receive |
|---|---|---|
| TPI ASM8 low dose | Active comparator | Not described Receives: Drug: TPI ASM8 |
| TPI ASM8 high dose | Active comparator | Not described Receives: Drug: TPI ASM8 |
| Placebo | Placebo comparator | Not described Receives: Drug: TPI ASM8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
The area under the curve fo the late asthmatic response(% fall in FEV1)(between 3-7 hrs post allergen challenge) will be compared between the 2 doses of TPI ASM8 and the placebo
Measured: Day 14 (Between 3-7 hr post-AIC)
Secondary outcomes (4)
Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment
Compare the % fall in FEV1 during the EAR and the LAR post-allergen challenge on Day 14.
Measured: Day 14
Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge
We will compare the PC20( provocative concentration of methacholine) that cause a 20% fall in FEV1
Measured: Day 13 and Day 15 (Pre & post AIC)
Effect of ASM8 on mast cells (as measured by specific biomarkers)
The leukotriene E4 and 9-11B PGF2 wil be measured in urine and plasma to determine the level of mast cells activation following the allergen challenge
Measured: Day 14 (pre, post and and peri-AIC)
Sputum inflammation indicators (Eos, neutrophils, etc.)
We will measure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo.
Measured: Day 14 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionFeb 2012
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul O'Byrne, MD, Study chair, McMaster UniversityRene Pageau, M.Sc Pharm, Study director, Pharmaxis LtdLouis-Philippe Boulet, MD, Principal investigator, Hopital Laval, QuebecRichard Leigh, MD, Principal investigator, University of CalgaryGail M Gauveau, PhD, Principal investigator, McMaster UniversityMark Fitzgerald, MD, Principal investigator, Vancouver Coastal Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158898
- Sponsor's protocol ID
- TPI ASM8-207
- Status last verified
- Nov 2013
- First submitted
- 17 Jun 2010
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
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 Double-Blind,Randomized, Placebo-controlled, 3-Way Cross Over Study to Evaluate the Efficacy and Safety of 14 Days TPI ASM8 in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT01158898
- Acronym / sponsor ID
- TPI ASM8-207
- Conditions
- Asthma
- Keywords
- Mild to moderate asthma, Allergen inhalation challenge
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Jul 2010 (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 is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.
Detailed description
Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TPI ASM8 low dose | Active comparator | Drug: TPI ASM8 |
| TPI ASM8 high dose | Active comparator | Drug: TPI ASM8 |
| Placebo | Placebo comparator | Drug: TPI ASM8 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mild asthma, male and female aged 18-55 y.old
- Steroid-naive, non-smoker
- Dual responders
Key exclusion criteria (3 listed)
- Any chronic disease(unstable)
- Immunosuppressed, recent or ongoing steroid intake
- Methacholine PC 20 > 16 mg/mL
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 ASM8ASM8 4mg/mL (low dose) daily for 14 days by inhalation | Drug | TPI ASM8 low dose |
| TPI ASM8ASM8 4mg/mL (high dose) daily for 14 days by inhalation | Drug | TPI ASM8 high dose |
| TPI ASM8Placebo PBS solution daily for 14 days by inhalation | Drug | Placebo |
Primary outcome
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
Time frame: Day 14 (Between 3-7 hr post-AIC)
The area under the curve fo the late asthmatic response(% fall in FEV1)(between 3-7 hrs post allergen challenge) will be compared between the 2 doses of TPI ASM8 and the placebo
4 secondary outcomes
Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment
Time frame: Day 14
Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge
Time frame: Day 13 and Day 15 (Pre & post AIC)
Effect of ASM8 on mast cells (as measured by specific biomarkers)
Time frame: Day 14 (pre, post and and peri-AIC)
Sputum inflammation indicators (Eos, neutrophils, etc.)
Time frame: Day 14 and Day 15
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.
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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.
Paul O'Byrne, MD study chair
McMaster University
Rene Pageau, M.Sc Pharm study director
Pharmaxis Ltd
Louis-Philippe Boulet, MD principal investigator
Hopital Laval, Quebec
4 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 in people with Asthma, run by Syntara at 4 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 3 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 4 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. Some participants in this study may receive a placebo. 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?
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo (time frame: Day 14 (Between 3-7 hr post-AIC)). 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.