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Study to Investigate Effects of CAL-101 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: NCT00836914
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: CAL-101 Drug: Placebo Phase 1

Detailed Description:
A Phase I, randomized, double-blind crossover study of CAL-101, an oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta, in patients with allergic rhinitis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 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-101 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge
Study Start Date : February 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Idelalisib

Arm Intervention/treatment
Active Comparator: CAL-101 Drug: CAL-101
CAL-101 100mg capsules administered orally twice a day (BID) for 7 days
Other Names:
  • Idelalisib
  • GS-1101

Placebo Comparator: Placebo Drug: Placebo
Placebo capsules administered orally BID for 7 days

Primary Outcome Measures :
  1. Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG [ Time Frame: Baseline to Day 35 ]

Secondary Outcome Measures :
  1. Change from baseline in total nasal symptom score [ Time Frame: Baseline to Day 35 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 > or = 18 and < or = 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 (> or = class 2) for grass pollen during the previous 12 months or at screening
  5. Is otherwise healthy, that is, free from clinically significant illness or disease as determined by medical history, physical examination and laboratory tests, including a normal 12-lead electrocardiogram (ECG)
  6. Has no conditions which would make the subject unlikely to be able to remain in the allergen challenge chamber for 4 hours
  7. Is available to complete all study procedures
  8. Is able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

  1. Is a female of childbearing potential (non-childbearing potential means documented surgery resulting in infertility or postmenopausal with no menses for at least 1 year)
  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, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases
  5. Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies, e.g. St. John's Wort. Paracetamol (< or = 2g/day) and as needed use of short-acting B2-agonists are allowed.
  6. Has taken a prohibited medication within the specified interval prior to Visit 1:

    • Corticosteroids (depot, 90 days; systemic, 30 days; dermatologic 14 days)
    • Chromones (14 days)
    • Antihistamines (nasal and long-acting oral, 10 days; shorting-acting oral, 2 days; ocular, 3 days)
    • Decongestants (3 days)
    • Leukotriene modifiers (10 days)
    • Anticholinergics (7 days)
    • Opthalmic nonsteroidal
    • anti-inflammatory drugs (3 days)
    • Nasal-ophthalmic wash solutions (12 hr)
    • Immunotherapy (12 hr)
  7. Is currently being treated with a medication that induces or inhibits cytochrome P450 (CYP)3A

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): NCT00836914

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Vienna Challenge Chamber
Vienna, Austria
Sponsors and Collaborators
Gilead Sciences
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Principal Investigator: Friedrich Horak, MD Vienna Challenge Chamber
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gilead Sciences Identifier: NCT00836914    
Other Study ID Numbers: 101-04
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: January 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
Keywords provided by Gilead Sciences:
Allergic Rhinitis
Phosphatidylinositol 3-kinase
Additional relevant MeSH terms:
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Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action