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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.
 
ClinicalTrials.gov Identifier: NCT00836914
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE February 2, 2009
First Posted Date  ICMJE February 4, 2009
Last Update Posted Date October 23, 2018
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2013)
Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG [ Time Frame: Baseline to Day 35 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
Safety - assessed using adverse events, vital signs, clinical laboratory tests, spirometry and ECG [ Time Frame: 35 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2013)
Change from baseline in total nasal symptom score [ Time Frame: Baseline to Day 35 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
Efficacy - total nasal symptom score [ Time Frame: 7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE
  • Drug: CAL-101
    CAL-101 100mg capsules administered orally twice a day (BID) for 7 days
    Other Names:
    • Idelalisib
    • GS-1101
  • Drug: Placebo
    Placebo capsules administered orally BID for 7 days
Study Arms  ICMJE
  • Active Comparator: CAL-101
    Intervention: Drug: CAL-101
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Horak F, Puri KD, Steiner BH, Holes L, Xing G, Zieglmayer P, Zieglmayer R, Lemell P, Yu A. Randomized phase 1 study of the phosphatidylinositol 3-kinase δ inhibitor idelalisib in patients with allergic rhinitis. J Allergy Clin Immunol. 2016 Jun;137(6):1733-1741. doi: 10.1016/j.jaci.2015.12.1313. Epub 2016 Feb 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2013)
41
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2009)
45
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00836914
Other Study ID Numbers  ICMJE 101-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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 http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Friedrich Horak, MD Vienna Challenge Chamber
PRS Account Gilead Sciences
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP