Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
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ClinicalTrials.gov Identifier: NCT00791973 |
Recruitment Status :
Completed
First Posted : November 17, 2008
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Rhinitis | Drug: fluticasone furoate Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Veramyst, then Placebo
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
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Drug: fluticasone furoate
2 puffs in each nostril once daily for 1 week
Other Name: Veramyst Drug: Placebo 2 puffs in each nostril once daily for 1 week |
Active Comparator: Placebo, then Veramyst
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
|
Drug: fluticasone furoate
2 puffs in each nostril once daily for 1 week
Other Name: Veramyst Drug: Placebo 2 puffs in each nostril once daily for 1 week |
- 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
- Total Eye Symptom Scores After Antigen Challenge [ Time Frame: After one week of treatment wtih veramyst or placebo ]Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791973
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Robert Naclerio, MD | University of Chicago |
Responsible Party: | Robert Naclerio, MD, University of Chicago |
ClinicalTrials.gov Identifier: | NCT00791973 |
Other Study ID Numbers: |
16367B (OC 3) |
First Posted: | November 17, 2008 Key Record Dates |
Results First Posted: | July 8, 2014 |
Last Update Posted: | July 8, 2014 |
Last Verified: | June 2014 |
Rhinitis Rhinitis, Allergic Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Fluticasone Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents |