A Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in Adults

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in Adult Men or Women Allergic to Mountain Cedar Pollen

The purpose of this study is to evaluate the clinical effectiveness, safety and pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: JNJ-17166864; Drug: Placebo

Detailed Description

The study is conducted to prove the hypothesis that JNJ-17466864, as compared to placebo, can provide a 16% or greater improvement in nasal symptoms of seasonal allergic rhinitis. This is a randomized, blinded, placebo-controlled, parallel-group, 2-center outpatient study in adult men or women who have seasonal allergic rhinitis and have 2 year history (or longer) of mild to moderate allergic reaction to mountain cedar pollen. The study will be conducted in mountain cedar pollen season. 72 qualified patients will be admitted to the single-blind 7-day Run-in Period (placebo twice daily) to establish the Baseline allergic rhinitis symptom scores. Patient eligibility to enter the double-blind treatment phase will be based on patients' baseline nasal symptom scores. At least 66 eligible patients whose daytime average nasal symptom scores (of nasal congestion, nasal itching, rhinorrhea, and sneezing) is 2 or greater, with the daytime nasal congestion symptom score 2 or greater, on at least 4 of the 7 Run-in days will be admitted to the double-blind treatment phase, and randomized to either the JNJ-17166864 or placebo treatment group. During the Treatment Phase, patients will self-administer study medication (0.5 mg JNJ-17166864 or placebo per nostril) twice daily for 2 weeks, record allergic rhinitis nasal and ocular symptom scores, and complete the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), to establish the In-Treatment scores. Pharmacokinetic and biomarker samples will be collected during treatment phase. Throughout the study, safety and tolerability will be assessed.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have a clinical history of seasonal allergic rhinitis with onset and offset of nasal allergy symptoms during each of the past 2 mountain cedar allergy seasons
• Have positive prick skin test reaction to mountain cedar allergen at screening or have a documented positive prick skin test within 12 months prior to entering the treatment phase
• Good general health on the basis of physical examination (including nasal examination), medical history, vital signs, and 12-lead ECG performed at screening and on Day -2
• Good general health on the basis of clinical laboratory tests performed at screening
• Have no history of recent (within 14 days prior to study drug administration on Day 1) common cold or recent (within 14 days prior to study drug administration on Day 1) occupational exposures to inhaled irritants (e.g., industrial gases, dusts, pesticides) with the exception of mountain cedar pollen
• Have no history of recurrent or frequent epistaxis or recent episodes (within 14 days prior to study drug administration on Day 1) of nose bleeding
• Non-smoker or non-tobacco user (not smoked cigarettes or used tobacco-containing or nicotine-containing products for at least 3 months prior to screening.

Exclusion Criteria:

• Have asthma (Note: subjects with mild intermittent asthma are allowed)
• Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent or super-potent topical corticosteroids
• Use of any antihistamines during the study
• Under immunotherapy with mountain cedar extract
• Using prohibited medications or not having adequate washout period (prior to the start of Run-in) as specified: Intranasal or systemic corticosteroids (1 month), Intranasal cromolyn (2 weeks), Intranasal or systemic decongestants (3 days), Intranasal or systemic antihistamines (7 days), Intranasal tryptans,e.g. sumatryptan nasal spray, Imitrex (3 days), Intranasal ergotamines, e.g. dihydroergotamine mesylate nasal spray, Migranol (7 days), Singulair (7 days), Niaspan® extended-release tablets, or immediate release niacin (10 days)
• Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
• Chronic use of concomitant medications including prescription medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication within 14 days prior to study drug administration on Day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo nasal spray twice daily for 2 weeks.
Experimental: JNJ-17166864	Drug: JNJ-17166864; JNJ-17166864 0.5 mg per nostril twice daily for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the effect of twice daily dosing of intranasal JNJ-17166864, compared to placebo, on nasal symptoms of seasonal allergic rhinitis (nasal congestion, nasal itching, rhinorrhea, and sneezing)	allergic rhinitis symptom score during treatment phase (2 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess safety, tolerability, and pharmacokinetics	pharmacokinetics and biomarker assessment during treatment phase (2 weeks)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: January 8, 2008
• First Submitted That Met QC Criteria: January 16, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: biomarkers; pharmacokinetics; allergic rhinitis; JNJ-17166864; rhinitis symptoms; mountain cedar pollen
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: CR014041; 17166864NAP2001 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)