Seasonal Allergic RhinitisPhase 2NCT02061670
Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma
A Phase 2 study testing Ragweed-SPIRE in people with Seasonal Allergic Rhinitis and Asthma, run by Circassia Limited at 5 sites in Canada.
Trial summary
The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis, Asthma
- What is being tested?
- Ragweed-SPIRE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 2014to Oct 2014
- 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
- Male or female, aged 18-65 years.
- Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation.
- A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons.
- Positive skin prick test to ragweed
- Ragweed-specific Immunoglobulin E (IgE) ≥ 0.35 kU/L.
Who cannot join
- History of life-threatening asthma.
- Uncontrolled asthma according to GINA
- FEV1 of < 70 % of predicted, regardless of the cause.
- Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- History of severe drug allergy or anaphylactic reaction to food.
- A history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Kanata Allergy Services
Kanata, Ontario, K2L 3C8
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Cheema Research Inc
Mississauga, Ontario, L5A 3V
Ottawa Allergy Research Corp
Ottawa, Ontario, K1Y 4G2
Inflamax Research
Toronto, Ontario, L4W 1A4
About this study
Official title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Ragweed-SPIRE in Subjects With Asthma and Ragweed-Induced Rhinoconjunctivitis
The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and asthma.
- Conditions
- Seasonal Allergic Rhinitis, Asthma
- Being tested
- Ragweed-SPIRE, Placebo
- Keywords
- Ragweed, Allergy, rhinoconjunctivitis, rhinitis, asthma
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Asthma, Hypersensitivity, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ragweed-SPIREBiological
Intradermal injection
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Ragweed-SPIRE 1 | Experimental | Ragweed-SPIRE regimen 1 given 2 weeks apart Receives: Biological: Ragweed-SPIRE |
| Ragweed-SPIRE 2 | Experimental | Ragweed-SPIRE regimen 2 given 2 weeks apart Receives: Biological: Ragweed-SPIRE |
| Placebo | Placebo comparator | Placebo given 2 weeks apart Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events as a measure of safety and tolerability
Measured: Throughout subjects participation in the study, approximately 22 weeks
Secondary outcomes (2)
Number of subjects with asthma exacerbations as a measure of safety and tolerability
Measured: Throughout subjects participation in the study, approximately 22 weeks
Evaluation of change in lung function as a measure of safety and tolerability
Measured: Throughout subjects participation in the study, approximately 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 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
- NCT02061670
- Sponsor's protocol ID
- TR007
- Status last verified
- Jan 2015
- First submitted
- 3 Feb 2014
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Ragweed-SPIRE in Subjects With Asthma and Ragweed-Induced Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT02061670
- Acronym / sponsor ID
- TR007
- Conditions
- Seasonal Allergic Rhinitis, Asthma
- Keywords
- Ragweed, Allergy, rhinoconjunctivitis, rhinitis, asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Feb 2014 (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 whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ragweed-SPIRE 1 | Experimental | Biological: Ragweed-SPIRERagweed-SPIRE regimen 1 given 2 weeks apart |
| Ragweed-SPIRE 2 | Experimental | Biological: Ragweed-SPIRERagweed-SPIRE regimen 2 given 2 weeks apart |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo given 2 weeks apart |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 18-65 years.
- Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation.
- A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons.
- Positive skin prick test to ragweed
- Ragweed-specific Immunoglobulin E (IgE) ≥ 0.35 kU/L.
Key exclusion criteria (6 listed)
- History of life-threatening asthma.
- Uncontrolled asthma according to GINA
- FEV1 of < 70 % of predicted, regardless of the cause.
- Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- History of severe drug allergy or anaphylactic reaction to food.
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 |
|---|---|---|
| Ragweed-SPIREIntradermal injection | Biological | Ragweed-SPIRE 1, Ragweed-SPIRE 2 |
| Placebo | Biological | Placebo |
Primary outcome
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: Throughout subjects participation in the study, approximately 22 weeks
2 secondary outcomes
Number of subjects with asthma exacerbations as a measure of safety and tolerability
Time frame: Throughout subjects participation in the study, approximately 22 weeks
Evaluation of change in lung function as a measure of safety and tolerability
Time frame: Throughout subjects participation in the study, approximately 22 weeks
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 21 Jan 2015.
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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.
5 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 Ragweed-SPIRE in people with Seasonal Allergic Rhinitis and Asthma, run by Circassia Limited at 5 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 5 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 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Number of subjects with adverse events as a measure of safety and tolerability (time frame: Throughout subjects participation in the study, approximately 22 weeks). 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 21 Jan 2015.