Clinical trial NCT00836914: Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
Allergy
Phosphatidylinositol 3-kinase
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG
timeFrame: Baseline to Day 35
Secondary outcomes:
measure: Change from baseline in total nasal symptom score
timeFrame: Baseline to Day 35
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Challenge Chamber
Study officials:
affiliation: Vienna Challenge Chamber
name: Friedrich Horak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 delta 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.