Allergic RhinitisPhase 4NCT00791973
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
A Phase 4 study testing fluticasone furoate in people with Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- fluticasone furoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to May 2010
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.
- Conditions
- Allergic Rhinitis
- Being tested
- fluticasone furoate, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone furoateDrug
Also called Veramyst
2 puffs in each nostril once daily for 1 week
PlaceboDrug
2 puffs in each nostril once daily for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Veramyst, then Placebo | Active comparator | fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week Receives: Drug: fluticasone furoate; Drug: Placebo |
| Placebo, then Veramyst | Active comparator | placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week Receives: Drug: fluticasone furoate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tryptase Level From Baseline to Post-antigen Challenge
Tryptase levels (mcg/L) were measured from nasal lavages
Measured: After one week of treatment wtih veramyst or placebo
Secondary outcomes (1)
Total Eye Symptom Scores After Antigen Challenge
Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe
Measured: After one week of treatment wtih veramyst or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionMay 2010
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 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 Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791973
- Sponsor's protocol ID
- 16367B (OC 3)
- Status last verified
- Jun 2014
- First submitted
- 13 Nov 2008
- Last updated
- 8 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
- ClinicalTrials.gov ID
- NCT00791973
- Acronym / sponsor ID
- 16367B (OC 3)
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 8 Jul 2014
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 help us to a better understanding of how nose and eye symptoms are related in patients with allergies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veramyst, then Placebo | Active comparator | Drug: fluticasone furoate, Drug: Placebofluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week |
| Placebo, then Veramyst | Active comparator | Drug: fluticasone furoate, Drug: Placeboplacebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week |
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 (3 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.
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 furoateAlso: Veramyst2 puffs in each nostril once daily for 1 week | Drug | Placebo, then Veramyst, Veramyst, then Placebo |
| Placebo2 puffs in each nostril once daily for 1 week | Drug | Placebo, then Veramyst, Veramyst, then Placebo |
Primary outcome
Change in Tryptase Level From Baseline to Post-antigen Challenge
Time frame: After one week of treatment wtih veramyst or placebo
Tryptase levels (mcg/L) were measured from nasal lavages
1 secondary outcome
Total Eye Symptom Scores After Antigen Challenge
Time frame: After one week of treatment wtih veramyst or placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Allergic Rhinitis
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
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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 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 fluticasone furoate in people with 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 3 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 Jul 2014. 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 8 Jul 2014). 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?
Change in Tryptase Level From Baseline to Post-antigen Challenge (time frame: After one week of treatment wtih veramyst or placebo). 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 Jul 2014.