Allergic Conjunctivitis to Tree Pollen or Grass PollenPhase 4NCT00891436
Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms
A Phase 4 study testing Fluticasone furoate nasal spray in people with Allergic Conjunctivitis to Tree Pollen or Grass Pollen, run by Rush University Medical Center at 1 site in United States.
Trial summary
Rationale and objectives: Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis to Tree Pollen or Grass Pollen
- What is being tested?
- Fluticasone furoate nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a documented history of allergic rhinitis and conjunctivitis due to tree pollen and / or grass pollen for two allergy seasons
- positive skin prick test to tree and / or grass
Who cannot join
- glaucoma
- cataracts
- acute or chronic sinusitis
- asthma
- chronic obstructive pulmonary disease
- physical nasal obstruction
Show all 16Show fewer
- pregnant or breastfeeding
- have had a viral or bacterial infections within 2 weeks of the study commencement
- receiving allergen immunotherapy
- have used inhaled corticosteroids within 14 days prior to the study
- have used systemic corticosteroids within 30 days of the study
- travel outside of the geographic area during the 2 week study period
- use of contact lenses during the study period
- use of artificial tears during the study period
- use of eyewash irrigation during the study period
- use of lubricants during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Comparison of the Effect of Fluticasone Furoate Nasal Spray Versus Placebo on Allergic Mediators in the Tears of Subjects With Tree or Grass Pollen Allergy
Rationale and objectives:
Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. Although this is the only published report of an intranasal corticosteroid shown to effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the tears of patients with allergic conjunctivitis are known to have increased concentrations of cytokines and allergic mediators.
The objective of this study is to determine if the positive effects of Veramyst nasal spray on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the amount of allergic mediators detected in their tears.
- Being tested
- Fluticasone furoate nasal spray, Placebo nasal spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoate nasal sprayDrug
Also called Veramyst
2 sprays each nostril every morning for 2 weeks
Placebo nasal sprayDrug
2 sprays each nostril every morning for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo nasal spray | Placebo comparator | Not described Receives: Drug: Placebo nasal spray |
| Fluticasone furoate nasal spray | Active comparator | Not described Receives: Drug: Fluticasone furoate nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eosinophilic Cationic Protein (ECP) Levels
Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.
Measured: Samples taken at initial visit & 2 week follow-up
Secondary outcomes (1)
Histamine Content in the Tears Was Measured.
Tear samples were assayed for histamine by ELISA
Measured: Samples taken at initial visit & 2 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic Conjunctivitis to Tree Pollen or Grass PollenStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, James Moy, Rush University Medical Center
- Investigators
- J. Moy, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891436
- Sponsor's protocol ID
- RUMCgsk 113002
- Status last verified
- Nov 2012
- First submitted
- 30 Apr 2009
- Last updated
- 3 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Fluticasone Furoate Nasal Spray Versus Placebo on Allergic Mediators in the Tears of Subjects With Tree or Grass Pollen Allergy
- ClinicalTrials.gov ID
- NCT00891436
- Acronym / sponsor ID
- RUMCgsk 113002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Posted 18 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale and objectives:
Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. Although this is the only published report of an intranasal corticosteroid shown to effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the tears of patients with allergic conjunctivitis are known to have increased concentrations of cytokines and allergic mediators.
The objective of this study is to determine if the positive effects of Veramyst nasal spray on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the amount of allergic mediators detected in their tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo nasal spray | Placebo comparator | Drug: Placebo nasal spray |
| Fluticasone furoate nasal spray | Active comparator | Drug: Fluticasone furoate nasal spray |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a documented history of allergic rhinitis and conjunctivitis due to tree pollen and / or grass pollen for two allergy seasons
- positive skin prick test to tree and / or grass
Key exclusion criteria (16 listed)
- glaucoma
- cataracts
- acute or chronic sinusitis
- asthma
- chronic obstructive pulmonary disease
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 |
|---|---|---|
| Fluticasone furoate nasal sprayAlso: Veramyst2 sprays each nostril every morning for 2 weeks | Drug | Fluticasone furoate nasal spray |
| Placebo nasal spray2 sprays each nostril every morning for 2 weeks | Drug | Placebo nasal spray |
Primary outcome
Eosinophilic Cationic Protein (ECP) Levels
Time frame: Samples taken at initial visit & 2 week follow-up
Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.
1 secondary outcome
Histamine Content in the Tears Was Measured.
Time frame: Samples taken at initial visit & 2 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
J. Moy, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone furoate nasal spray in people with Allergic Conjunctivitis to Tree Pollen or Grass Pollen, run by Rush University Medical Center at 1 site in United States.
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 2 inclusion and 16 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 3 Dec 2012. 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 States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Eosinophilic Cationic Protein (ECP) Levels (time frame: Samples taken at initial visit & 2 week follow-up). 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 3 Dec 2012.