Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066611
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : May 5, 2011
Information provided by:
Gilead Sciences

Brief Summary:
The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: CAL-263 Drug: Placebo Phase 1

Detailed Description:
A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2010
Primary Completion Date : April 2010
Study Completion Date : April 2010

Arm Intervention/treatment
Active Comparator: 1
Drug: CAL-263
CAL-263 10 mg or placebo once daily for 7 days
Placebo Comparator: 2
Drug: Placebo
CAL-263 10 mg or placebo once daily for 7 days

Primary Outcome Measures :
  1. Evaluate the safety of CAL-263 in allergic rhinitis subjects [ Time Frame: 46 days ]

Secondary Outcome Measures :
  1. Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age >18 and <55 years
  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:

  1. Is a female of childbearing
  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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01066611

Vienna Challenge Chamber
Vienna, Austria
Sponsors and Collaborators
Gilead Sciences
Principal Investigator: Friedrich Horak, MD Vienna Challenge Chamber

Responsible Party: Langdon Miller, M.D., VP Clinical Research, Oncology, Gilead Sciences Identifier: NCT01066611     History of Changes
Other Study ID Numbers: 263-02
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: May 5, 2011
Last Verified: May 2011

Keywords provided by Gilead Sciences:
Allergic Rhinitis
Phosphatidylinositol 3-kinase

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases