Allergic AsthmaPhase 2NCT00550797
Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma
A Phase 2 study testing TPI ASM8 in people with Allergic Asthma, run by Syntara at 1 site in United Kingdom.
Trial summary
The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- TPI ASM8
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Oct 2008
- 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
- Men and women 18 to 65 years of age
- Intermittent mild to moderate allergic asthma as defined by ATS/ERS criteria
- History of episodic wheeze and shortness of breath
Who cannot join
- Significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness, asthma exacerbation or respiratory infection in the preceding 6 weeks
- Use of oral/injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs or anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of 14-day Inhaled TPI ASM8 in Subjects With Asthma
The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.
Read the detailed description
Early and late asthmatic responses were attenuated by ASM8 and by placebo solution.Methacholine challenge was not affected by study medication. Other parameters were unchanged.
- Conditions
- Allergic Asthma
- Being tested
- TPI ASM8, placebo
- Keywords
- Steroid-naive, non-smokers, Mild to moderate allergic asthmatic adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI ASM8Biological
Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
placeboBiological
Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
| Study group | Role | What they receive |
|---|---|---|
| No.1 ASM8 (oligonucleotide) | Experimental | TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation Receives: Biological: TPI ASM8 |
| Phosphate Buffer solution | Placebo comparator | Placebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response
Measured: Safety (Trial duration) + LAR (Day 14)
Secondary outcomes (1)
Exploratory Endpoints only: EAR on Day 14, AMP-induced airway hyperresponsiveness on Day 10,eNO on Day 14, PK/PD in sputum and plasma
Measured: study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- i3 Research
- Responsible party
- Sponsor
- Investigators
- Brian O'Connor, MD, Principal investigator, Kings College Hospital, London, United KingdomRene Pageau, M.Sc.Pharm, Study director, Topigen Pharmaceuticals, Montreal, Quebec/CanadaPierluigi Paggiaro, Prof, Principal investigator, University of Pisa, Pisa, ItalyDave Singh, MD, Principal investigator, Evaluation Unit, Manchester, UKPeter J. Sterk, MD, Principal investigator, University of Amsterdam, Amsterdam, The NetherlandsPiero Maestrelli, Prof., Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550797
- Sponsor's protocol ID
- TPI ASM8-205
- Status last verified
- Nov 2013
- First submitted
- 26 Oct 2007
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of 14-day Inhaled TPI ASM8 in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00550797
- Acronym / sponsor ID
- TPI ASM8-205
- Conditions
- Allergic Asthma
- Keywords
- Steroid-naive, non-smokers, Mild to moderate allergic asthmatic adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Collaborators
- i3 Research
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 Oct 2007 (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.
The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.
Detailed description
Early and late asthmatic responses were attenuated by ASM8 and by placebo solution.Methacholine challenge was not affected by study medication. Other parameters were unchanged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No.1 ASM8 (oligonucleotide) | Experimental | Biological: TPI ASM8TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation |
| Phosphate Buffer solution | Placebo comparator | Biological: placeboPlacebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 18 to 65 years of age
- Intermittent mild to moderate allergic asthma as defined by ATS/ERS criteria
- History of episodic wheeze and shortness of breath
Key exclusion criteria (2 listed)
- Significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness, asthma exacerbation or respiratory infection in the preceding 6 weeks
- Use of oral/injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs or anticoagulants
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 ASM8Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each | Biological | No.1 ASM8 (oligonucleotide) |
| placeboAdministered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each | Biological | Phosphate Buffer solution |
Primary outcome
Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response
Time frame: Safety (Trial duration) + LAR (Day 14)
1 secondary outcome
Exploratory Endpoints only: EAR on Day 14, AMP-induced airway hyperresponsiveness on Day 10,eNO on Day 14, PK/PD in sputum and plasma
Time frame: study duration
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 20 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.
Brian O'Connor, MD principal investigator
Kings College Hospital, London, United Kingdom
Rene Pageau, M.Sc.Pharm study director
Topigen Pharmaceuticals, Montreal, Quebec/Canada
Pierluigi Paggiaro, Prof principal investigator
University of Pisa, Pisa, Italy
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 Allergic Asthma, run by Syntara at 1 site in United Kingdom.
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 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: finished, as of the sponsor's last update on 20 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 United Kingdom. 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?
Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response (time frame: Safety (Trial duration) + LAR (Day 14)). 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 20 Nov 2013.