Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-263 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 27, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMay 5, 2011
May 1, 2011
3 months
January 27, 2010
May 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety of CAL-263 in allergic rhinitis subjects
46 days
Secondary Outcomes (1)
Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects
7 days
Study Arms (2)
1
ACTIVE COMPARATORCAL-263
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Age \>18 and \<55 years
- Has a history of seasonal allergic rhinitis for at least 2 years
- Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
- Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during the previous 12 months or at screening
- Is otherwise healthy
- Is able to provide written informed consent
You may not qualify if:
- Is a female of childbearing
- History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
- History of nonallergic rhinitis, chronic sinusitis or severe asthma
- Has a nasal condition likely to affect the outcome of the study
- Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies
- Has taken a prohibited medication within the specified interval prior to Visit 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (1)
Vienna Challenge Chamber
Vienna, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Friedrich Horak, MD
Vienna Challenge Chamber
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 27, 2010
First Posted
February 10, 2010
Study Start
January 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
May 5, 2011
Record last verified: 2011-05