Grass AllergyNCT02075138
Grass Observational Study
An observational study of Grass Allergy and Rhinoconjunctivitis, run by Circassia Limited at 7 sites in 3 countries.
Trial summary
Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis. The purpose of the current study is to evaluate allergy symptoms and allergy medication in subjects with grass-related rhinoconjunctivitis. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Grass Allergy, Rhinoconjunctivitis
- How many people
- 109 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Apr 2014to Mar 2015
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with a history of Grass induced Rhinoconjunctivitis
Who may be able to join
- History of moderate to severe rhinoconjunctivitis consistent with allergy to grass for at least 2 years.
- Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
- Perennial Rye grass or Timothy grass-specific IgE ≥ 0.35 kU/L as measured by ImmunoCAP®.
- Positive skin prick test to Perennial Rye grass or Timothy grass allergen
Who cannot join
- Positive skin prick test ≥ 5 mm to any confounding, co-existing seasonal allergens likely to be present during the pre-season baseline and grass pollen period.
- Medical records of symptomatic perennial allergic rhinitis and/or asthma or a positive skin test ≥ 5 mm due to a perennial allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and which cannot be avoided during the course of the study.
- Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
- Subjects who had been treated with any non-grass licensed allergen immunotherapy extracts or non-grass investigational immunotherapy for more than 1 month within 1 year.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States5 sites
Study site
Medford, Oregon
Study site
Normal, Illinois
Study site
Spokane, Washington
Study site
Sylvania, Ohio
Study site
Washington D.C., District of Columbia
About this study
Official title: An Observational Multi-Centre Field Study to Assess Symptom Scores and Allergy Medication Usage in Subjects With a History of Grass-Induced Rhinoconjunctivitis
Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis.
The purpose of the current study is to evaluate allergy symptoms and allergy medication in subjects with grass-related rhinoconjunctivitis.
- Conditions
- Grass Allergy, Rhinoconjunctivitis
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 |
|---|---|---|
| Grass-Induced Rhinoconjunctivitis Subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grass AllergyStudies 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
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, CIDAL
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075138
- Sponsor's protocol ID
- TG003
- Status last verified
- Apr 2015
- First submitted
- 20 Feb 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Multi-Centre Field Study to Assess Symptom Scores and Allergy Medication Usage in Subjects With a History of Grass-Induced Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT02075138
- Acronym / sponsor ID
- TG003
- Conditions
- Grass Allergy, Rhinoconjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health, CIDAL
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Mar 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.
Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis.
The purpose of the current study is to evaluate allergy symptoms and allergy medication in subjects with grass-related rhinoconjunctivitis.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grass-Induced Rhinoconjunctivitis Subjects | – | – |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with a history of Grass induced Rhinoconjunctivitis
Key inclusion criteria (4 listed)
- History of moderate to severe rhinoconjunctivitis consistent with allergy to grass for at least 2 years.
- Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
- Perennial Rye grass or Timothy grass-specific IgE ≥ 0.35 kU/L as measured by ImmunoCAP®.
- Positive skin prick test to Perennial Rye grass or Timothy grass allergen
Key exclusion criteria (4 listed)
- Positive skin prick test ≥ 5 mm to any confounding, co-existing seasonal allergens likely to be present during the pre-season baseline and grass pollen period.
- Medical records of symptomatic perennial allergic rhinitis and/or asthma or a positive skin test ≥ 5 mm due to a perennial allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and which cannot be avoided during the course of the study.
- Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
- Subjects who had been treated with any non-grass licensed allergen immunotherapy extracts or non-grass investigational immunotherapy for more than 1 month within 1 year.
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
To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score
Time frame: 6 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 8 Apr 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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Grass Allergy and Rhinoconjunctivitis, run by Circassia Limited at 7 sites in 3 countries.
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 4 inclusion and 4 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Argentina, Chile. 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?
To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score (time frame: 6 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 8 Apr 2015.