Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber

NCT00836914 | Completed Phase 1

• 1 other identifier: 101-04
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis; Allergy; Phosphatidylinositol 3-kinase

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG

  Baseline to Day 35

Secondary Outcomes (1)

• Change from baseline in total nasal symptom score

  Baseline to Day 35

Study Arms (2)

CAL-101

ACTIVE COMPARATOR

Drug: CAL-101

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CAL-101 DRUG

CAL-101 100mg capsules administered orally twice a day (BID) for 7 days

Also known as: Idelalisib, GS-1101

CAL-101

Placebo DRUG

Placebo capsules administered orally BID for 7 days

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> or = 18 and \< or = 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 (\> or = class 2) for grass pollen during the previous 12 months or at screening
• 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)
• Has no conditions which would make the subject unlikely to be able to remain in the allergen challenge chamber for 4 hours
• Is available to complete all study procedures
• Is able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form

You may not qualify if:

• 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)
• 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, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases
• 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.
• 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)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Vienna Challenge Chamber

Vienna, Austria

Location

Related Publications (1)

• 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.

  PMID: 26915677 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic; Hypersensitivity

Interventions

idelalisib

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Friedrich Horak, MD

  Vienna Challenge Chamber

  PRINCIPAL INVESTIGATOR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 23, 2018

Record last verified: 2013-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

AU (1)