Seasonal Allergic RhinitisPhase 4NCT01007253
Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms
A Phase 4 study testing PL nasal spray, fluticasone furoate (FF) and PL eye drops in people with Seasonal Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
People who have hayfever or allergic rhinitis often complain about eye symptoms associated with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The purpose of this study is to better understand the generation of eye symptoms in patients with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- PL nasal spray, fluticasone furoate (FF) and PL eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between 18 and 45 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin test to grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
Who cannot join
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
- forced expiratory volume at one second (FEV1) <80% of predicted at screening for subjects with history of mild asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution Alone and In Combination on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen.
People who have hayfever or allergic rhinitis often complain about eye symptoms associated with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The purpose of this study is to better understand the generation of eye symptoms in patients with allergic rhinitis. We have previously shown that placing the substance that subjects are allergic to in their nose causes both nose and eye symptoms. This can be explain by a parasympathetic neurogenic reflex from the nose to the eye. Such a reflex would readily explain the tearing and watery eye symptoms, but does not explain the itch. In this study, we are going to address one possible explanation for the itch; does an axonal neurogenic reflex stimulate mast cells in the eye to release histamine, which then causes the itch? We will do this by placing an antihistamine drop in the eye and challenge the nose with allergen. We will also attempt to demonstrate that mast activation isn't effected by blocking the initiating of the reflex with a nasal steroid, as done in our previous study, and showing that the addition of an antihistamine does not add to the reduction of symptoms.
Read the detailed description
We performed a randomized, double-blind, double-dummy, placebo-controlled, four-way crossover study in 21 subjects with seasonal allergic rhinitis studied out of season. Healthy patients, between 18 and 50 years of age, came to the Nasal Physiology Laboratory at The University of Chicago for screening, where they completed an allergy questionnaire and underwent skin puncture testing for confirmation of allergy to grass or ragweed. Female subjects were given pregnancy tests. Patients who were eligible then underwent a screening nasal challenge with either grass or ragweed allergen depending on their skin test results and history. The study was approved by the Institutional Review Board at The University of Chicago and all of the patients gave written informed consent before entry.
After a 2-week washout period, after the screening challenge, 21 subjects who had positive screening challenge returned to the Nasal Physiology Laboratory where they were randomized to receive 1 week of one of four treatments:
- placebo (PL) nasal spray and PL eye drops (PL/PL),
- PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),
- fluticasone furoate (FF, also known as Veramyst) nasal spray and PL eye drops (FF/PL), and
- FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO).
Specifically, the PL eye drops used were lubricant eye drops with active ingredients of 0.3% glycerin and 1.0% propylene glycol and the PL nasal spray was provided by GlaxoSmithKline. Treatment with OLO consisted of 1 drop of 0.2% OLO in each eye daily and treatment of FF consisted of 2 puffs in each nostril daily, giving a total of 110 micrograms delivered in each nostril. After a week of each of the treatments, the subjects returned to the Nasal Physiology Laboratory to undergo a nasal challenge. The subjects then returned the next day while still receiving treatment for another nasal challenge to augment the nasal ocular reflex. Next, the patients had a 2-week washout period and then switched over to the next randomized treatment arm. This sequence was repeated until subjects completed all four arms of the trial.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- PL nasal spray, fluticasone furoate (FF), PL eye drops, olopatadine (OLO)
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PL nasal sprayDrug
2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week
fluticasone furoate (FF)Drug
Also called Veramyst
2 puffs of FF nasal spray in each nostril once a day for 1 week
PL eye dropsDrug
1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week
olopatadine (OLO)Drug
Also called Olopatadine 0.2% ophthalmic solution
1 drop of OLO eye drops in each eye once a day for 1 week
| Study group | Role | What they receive |
|---|---|---|
| FF/PL, PL/OLO, FF/OLO, PL/PL | Other | Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:
* fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)
* PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),
* FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), and
* placebo (PL) nasal spray and PL eye drops (PL/PL). Receives: Drug: PL nasal spray; Drug: fluticasone furoate (FF); Drug: PL eye drops; Drug: olopatadine (OLO) |
| PL/OLO, FF/OLO, PL/PL, FF/PL | Other | Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:
* PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),
* FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),
* placebo (PL) nasal spray and PL eye drops (PL/PL), and
* fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL). Receives: Drug: PL nasal spray; Drug: fluticasone furoate (FF); Drug: PL eye drops; Drug: olopatadine (OLO) |
| FF/OLO, PL/PL, FF/PL, PL/OLO | Other | Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:
* FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),
* placebo (PL) nasal spray and PL eye drops (PL/PL),
* fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), and
* PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO). Receives: Drug: PL nasal spray; Drug: fluticasone furoate (FF); Drug: PL eye drops; Drug: olopatadine (OLO) |
| PL/PL, FF/PL, PL/OLO, FF/OLO | Other | Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:
* placebo (PL) nasal spray and PL eye drops (PL/PL),
* fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL),
* PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), and
* FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO). Receives: Drug: PL nasal spray; Drug: fluticasone furoate (FF); Drug: PL eye drops; Drug: olopatadine (OLO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Eye Symptoms Score Difference
After treatment, each participant was subjected to a diluent (control) challenge in one eye and was asked to rate 2 eye symptoms (watery and itchy) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of watery and itchy eye symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other eye. The outcome is the total of the score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (watery and itchy), and eyes (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.
Measured: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Secondary outcomes (5)
Total Nasal Symptoms Score Difference
After treatment, each participant was subjected to a diluent (control) challenge in one nostril and was asked to rate nasal symptoms (congestion, rhinorrhea, and itchy nose/throat) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of nasal symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other nostril. The outcome is the total number of score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (congestion, rhinorrhea, and itchy nose/throat), and nostrils (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.
Measured: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Total Number of Sneezes
Measured: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Change in Histamine Level (Across Nasal Challenges)
Histamines are simple chemical substances produced by immune system cells when reacting to an antigen in response to foreign invaders like germs and bacteria.
Histamine in nasal lavages was measured using a histamine enzyme immunoassay kit market by SPI-BIo, Bertin Pharma (Montigny le Bretonneux, France). The limit of detection of the assay is 0.4 nM, and levels below the detection limit were arbitrarily assigned a value of 0.2 nM. Samples that yielded values above the upper detection limit of the assay were diluted and reassayed.
For each patient, histamine levels recorded after the diluent challenge were subtracted from histamine levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in histamine level reported in this outcome for each patient.
Measured: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Change in Tryptase Level (Across Nasal Challenges)
Tryptase is an enzyme that is released, along with histamine and other chemicals, from mast cells when they are activated, often as part of an allergic immune response. Tryptase in nasal lavages was measured using the ImmunoCap tryptase assay, by Phadia (Uppsala, Sweden). The limit of detection of the assay is 1.0 ng/mL, and levels below this value were arbitrarily assigned a value of 0.5 ng/mL.
For each patient, tryptase levels recorded after the diluent challenge were subtracted from tryptase levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in tryptase level reported in this outcome for each patient.
Measured: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Total Number of Eosinophils
The percentage of eosinophils among white blood cells was determined under light microscopy at 1000x magnification, and the total number of eosinophils in each lavage was then calculated. The specimens that had no eosinophils identified on differential counting despite adequate cells on the smear were assigned a number that corresponded to the lowest number of eosinophils on a slide where the number could be counted. That number was 33 total eosinophils.
Measured: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010
- Study completionAug 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Robert Naclerio, University of Chicago
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007253
- Sponsor's protocol ID
- 09-287-B
- Status last verified
- Jun 2013
- First submitted
- 3 Nov 2009
- Last updated
- 17 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Baroody FM, Logothetis H, Vishwanath S, Bashir M, Detineo M, Naclerio RM. Effect of intranasal fluticasone furoate and intraocular olopatadine on nasal and ocular allergen-induced symptoms. Am J Rhinol Allergy. 2013 Jan;27(1):48-53. doi: 10.2500/ajra.2013.27.3841.
PubMed 23406601
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution Alone and In Combination on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen.
- ClinicalTrials.gov ID
- NCT01007253
- Acronym / sponsor ID
- 09-287-B
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Posted 17 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People who have hayfever or allergic rhinitis often complain about eye symptoms associated with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The purpose of this study is to better understand the generation of eye symptoms in patients with allergic rhinitis. We have previously shown that placing the substance that subjects are allergic to in their nose causes both nose and eye symptoms. This can be explain by a parasympathetic neurogenic reflex from the nose to the eye. Such a reflex would readily explain the tearing and watery eye symptoms, but does not explain the itch. In this study, we are going to address one possible explanation for the itch; does an axonal neurogenic reflex stimulate mast cells in the eye to release histamine, which then causes the itch? We will do this by placing an antihistamine drop in the eye and challenge the nose with allergen. We will also attempt to demonstrate that mast activation isn't effected by blocking the initiating of the reflex with a nasal steroid, as done in our previous study, and showing that the addition of an antihistamine does not add to the reduction of symptoms.
Detailed description
We performed a randomized, double-blind, double-dummy, placebo-controlled, four-way crossover study in 21 subjects with seasonal allergic rhinitis studied out of season. Healthy patients, between 18 and 50 years of age, came to the Nasal Physiology Laboratory at The University of Chicago for screening, where they completed an allergy questionnaire and underwent skin puncture testing for confirmation of allergy to grass or ragweed. Female subjects were given pregnancy tests. Patients who were eligible then underwent a screening nasal challenge with either grass or ragweed allergen depending on their skin test results and history. The study was approved by the Institutional Review Board at The University of Chicago and all of the patients gave written informed consent before entry.
After a 2-week washout period, after the screening challenge, 21 subjects who had positive screening challenge returned to the Nasal Physiology Laboratory where they were randomized to receive 1 week of one of four treatments:
- placebo (PL) nasal spray and PL eye drops (PL/PL),
- PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),
- fluticasone furoate (FF, also known as Veramyst) nasal spray and PL eye drops (FF/PL), and
- FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO).
Specifically, the PL eye drops used were lubricant eye drops with active ingredients of 0.3% glycerin and 1.0% propylene glycol and the PL nasal spray was provided by GlaxoSmithKline. Treatment with OLO consisted of 1 drop of 0.2% OLO in each eye daily and treatment of FF consisted of 2 puffs in each nostril daily, giving a total of 110 micrograms delivered in each nostril. After a week of each of the treatments, the subjects returned to the Nasal Physiology Laboratory to undergo a nasal challenge. The subjects then returned the next day while still receiving treatment for another nasal challenge to augment the nasal ocular reflex. Next, the patients had a 2-week washout period and then switched over to the next randomized treatment arm. This sequence was repeated until subjects completed all four arms of the trial.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FF/PL, PL/OLO, FF/OLO, PL/PL | Other | Drug: PL nasal spray, Drug: fluticasone furoate (FF), Drug: PL eye drops, Drug: olopatadine (OLO)Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order: * fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL) * PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), * FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), and * placebo (PL) nasal spray and PL eye drops (PL/PL). |
| PL/OLO, FF/OLO, PL/PL, FF/PL | Other | Drug: PL nasal spray, Drug: fluticasone furoate (FF), Drug: PL eye drops, Drug: olopatadine (OLO)Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order: * PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), * FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), * placebo (PL) nasal spray and PL eye drops (PL/PL), and * fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL). |
| FF/OLO, PL/PL, FF/PL, PL/OLO | Other | Drug: PL nasal spray, Drug: fluticasone furoate (FF), Drug: PL eye drops, Drug: olopatadine (OLO)Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order: * FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), * placebo (PL) nasal spray and PL eye drops (PL/PL), * fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), and * PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO). |
| PL/PL, FF/PL, PL/OLO, FF/OLO | Other | Drug: PL nasal spray, Drug: fluticasone furoate (FF), Drug: PL eye drops, Drug: olopatadine (OLO)Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order: * placebo (PL) nasal spray and PL eye drops (PL/PL), * fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), * PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), and * FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females between 18 and 45 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin test to grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
Key exclusion criteria (4 listed)
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
- forced expiratory volume at one second (FEV1) <80% of predicted at screening for subjects with history of mild asthma.
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 |
|---|---|---|
| PL nasal spray2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week | Drug | FF/OLO, PL/PL, FF/PL, PL/OLO, FF/PL, PL/OLO, FF/OLO, PL/PL, PL/OLO, FF/OLO, PL/PL, FF/PL, PL/PL, FF/PL, PL/OLO, FF/OLO |
| fluticasone furoate (FF)Also: Veramyst2 puffs of FF nasal spray in each nostril once a day for 1 week | Drug | FF/OLO, PL/PL, FF/PL, PL/OLO, FF/PL, PL/OLO, FF/OLO, PL/PL, PL/OLO, FF/OLO, PL/PL, FF/PL, PL/PL, FF/PL, PL/OLO, FF/OLO |
| PL eye drops1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week | Drug | FF/OLO, PL/PL, FF/PL, PL/OLO, FF/PL, PL/OLO, FF/OLO, PL/PL, PL/OLO, FF/OLO, PL/PL, FF/PL, PL/PL, FF/PL, PL/OLO, FF/OLO |
| olopatadine (OLO)Also: Olopatadine 0.2% ophthalmic solution1 drop of OLO eye drops in each eye once a day for 1 week | Drug | FF/OLO, PL/PL, FF/PL, PL/OLO, FF/PL, PL/OLO, FF/OLO, PL/PL, PL/OLO, FF/OLO, PL/PL, FF/PL, PL/PL, FF/PL, PL/OLO, FF/OLO |
Primary outcome
Total Eye Symptoms Score Difference
Time frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
After treatment, each participant was subjected to a diluent (control) challenge in one eye and was asked to rate 2 eye symptoms (watery and itchy) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of watery and itchy eye symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other eye. The outcome is the total of the score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (watery and itchy), and eyes (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.
5 secondary outcomes
Total Nasal Symptoms Score Difference
Time frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Total Number of Sneezes
Time frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Change in Histamine Level (Across Nasal Challenges)
Time frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Change in Tryptase Level (Across Nasal Challenges)
Time frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Total Number of Eosinophils
Time frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23406601Baroody FM, Logothetis H, Vishwanath S, Bashir M, Detineo M, Naclerio RM. Effect of intranasal fluticasone furoate and intraocular olopatadine on nasal and ocular allergen-induced symptoms. Am J Rhinol Allergy. 2013 Jan;27(1):48-53. doi: 10.2500/ajra.2013.27.3841.
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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.
Robert M Naclerio, MD principal investigator
University of Chicago
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 PL nasal spray, fluticasone furoate (FF) and PL eye drops in people with Seasonal Allergic Rhinitis, run by University of Chicago 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 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 17 Jul 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 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. 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 17 Jul 2013). 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?
Total Eye Symptoms Score Difference (time frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01007253, which also lists 1 linked publication.
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 17 Jul 2013.