Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
NCT ID: NCT01066611
Last Updated: 2011-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2010-01-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
CAL-263
CAL-263
CAL-263 10 mg or placebo once daily for 7 days
2
Placebo
Placebo
CAL-263 10 mg or placebo once daily for 7 days
Interventions
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CAL-263
CAL-263 10 mg or placebo once daily for 7 days
Placebo
CAL-263 10 mg or placebo once daily for 7 days
Eligibility Criteria
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Inclusion Criteria
2. Has a history of seasonal allergic rhinitis for at least 2 years
3. Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
4. Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during the previous 12 months or at screening
5. Is otherwise healthy
6. Is able to provide written informed consent
Exclusion Criteria
2. History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
3. History of nonallergic rhinitis, chronic sinusitis or severe asthma
4. Has a nasal condition likely to affect the outcome of the study
5. Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies
6. Has taken a prohibited medication within the specified interval prior to Visit 1
18 Years
55 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Gilead Sciences
Principal Investigators
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Friedrich Horak, MD
Role: PRINCIPAL_INVESTIGATOR
Vienna Challenge Chamber
Locations
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Vienna Challenge Chamber
Vienna, , Austria
Countries
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Other Identifiers
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263-02
Identifier Type: -
Identifier Source: org_study_id
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