RhinoconjunctivitisNCT02396680
Ragweed-SPIRE Follow-On Study
An observational study of Rhinoconjunctivitis and Ragweed Allergy, run by Circassia Limited at 3 sites in Canada.
Trial summary
The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoconjunctivitis, Ragweed Allergy
- How many people
- 249 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2015to Feb 2016
- Phase
- Observational
- 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
Study population: Subjects who completed at least 6 of 8 treatment visits in Study TR006
Who may be able to join
- ° Previously randomised into and completed at least 6 of 8 treatment visits in Study TR006
Who cannot join
- Subject or Investigator have been informed of treatment received in Study TR006
- Subjects with significant allergy to animal dander
- Any allergen immunotherapy since completing Study TR006 or use of prohibited therapies
- History of recurrent acute sinusitis or chronic sinusitis
- Received treatment with an investigational drug within 4 weeks of Screening
- Unable to understand study requirements or unable to communicate clearly with Investigator
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Kanata Allergy Services
Kanata, Ontario, K2L 3C8
Inflamax Research
Mississauga, Ontario
Windsor Allergy Asthma Associates
Windsor, Ontario, N8X 2G1
About this study
Official title: An Observational Follow-On Field Study to Evaluate the Continued Efficacy and Safety of Ragweed-SPIRE Treatment in Ragweed Allergic Subjects Approximately One Year After the Completion of Treatment
The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose.
- Conditions
- Rhinoconjunctivitis, Ragweed Allergy
- Keywords
- Ragweed Allergy, Rhinoconjunctivitis, Immunotherapy, Ragweed-SPIRE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TR006 Subjects | Subjects that have previously been randomised into study TR006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Rhinoconjunctivitis Symptom Score
Measured: Approximately 12 months after first dose in TR006
Secondary outcomes (4)
Rescue Medication Score
Measured: Approximately 12 months after first dose in TR006
Patient Global Assessment
Measured: Approximately 12 months after first dose in TR006
Skin Prick Test
Measured: Approximately 12 months after first dose in TR006
Immunoglobulin E Test
Measured: Approximately 12 months after first dose in TR006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoconjunctivitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396680
- Sponsor's protocol ID
- TR006A
- Status last verified
- Mar 2016
- First submitted
- 19 Mar 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Follow-On Field Study to Evaluate the Continued Efficacy and Safety of Ragweed-SPIRE Treatment in Ragweed Allergic Subjects Approximately One Year After the Completion of Treatment
- ClinicalTrials.gov ID
- NCT02396680
- Acronym / sponsor ID
- TR006A
- Conditions
- Rhinoconjunctivitis, Ragweed Allergy
- Keywords
- Ragweed Allergy, Rhinoconjunctivitis, Immunotherapy, Ragweed-SPIRE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- First posted
- 24 Mar 2015 (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 purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TR006 Subjects | – | –Subjects that have previously been randomised into study TR006 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who completed at least 6 of 8 treatment visits in Study TR006
Key inclusion criteria (1 listed)
- ° Previously randomised into and completed at least 6 of 8 treatment visits in Study TR006
Key exclusion criteria (6 listed)
- Subject or Investigator have been informed of treatment received in Study TR006
- Subjects with significant allergy to animal dander
- Any allergen immunotherapy since completing Study TR006 or use of prohibited therapies
- History of recurrent acute sinusitis or chronic sinusitis
- Received treatment with an investigational drug within 4 weeks of Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Rhinoconjunctivitis Symptom Score
Time frame: Approximately 12 months after first dose in TR006
4 secondary outcomes
Rescue Medication Score
Time frame: Approximately 12 months after first dose in TR006
Patient Global Assessment
Time frame: Approximately 12 months after first dose in TR006
Skin Prick Test
Time frame: Approximately 12 months after first dose in TR006
Immunoglobulin E Test
Time frame: Approximately 12 months after first dose in TR006
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 23 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinoconjunctivitis and Ragweed Allergy, run by Circassia Limited at 3 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 1 inclusion and 6 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 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Total Rhinoconjunctivitis Symptom Score (time frame: Approximately 12 months after first dose in TR006). 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 23 Mar 2016.