Clinical trial NCT00804687: An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis
Official title: A Randomized, Single-Dose, Single-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-Over Study to Compare the Relative Efficacy of JNJ-39220675, Pseudoephedrine and Placebo for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergy
Rhinitis
Allergic Rhinitis
JNJ-39220675
Pseudoephedrine
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and pseudoephedrine compared to placebo (medication with no active ingredients) in participants with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen, dust or animal hair).

Detailed description: This is a randomized (the study drug is assigned by chance), single-dose, single-blind (a clinical trial in which the person giving the treatment, but not the participant, knows which treatment the participant is receiving), double-dummy, placebo-controlled, three-treatment period, cross-over (participants may receive different interventions sequentially during the trial) study of JNJ-39220675 in participants with allergic rhinitis. The duration of study will be 20-64 days per participant. The study consists of 2 parts: Screening (that is, 30 days before study commences on Day 1) and Treatment (consists of single-dose of either JNJ-39220675 solution \[10 milligram\], Pseudoephedrine tablet \[60 milligram\] or Placebo, in subsequent three-treatment periods, each separated with washout period of 6 days). All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences. Participants will be given dose approximately 2 hours before entry into the environmental exposure chamber where they will be exposed to ragweed pollen for 8 hours. Efficacy will primarily be evaluated by measurement of nasal congestion that will be assessed through nasal cavity geometry that is, minimal cross-sectional area of nasal cavity by Acoustic rhinometry. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants must have a clinical history of seasonal allergic rhinitis with seasonal onset and offset of nasal allergy symptoms at least during each of the last two ragweed allergy seasons
* Participants must have documentation of a positive skin test within 12 months of Screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal test (allergy tests performed by injecting allergy-causing substances underneath the skin to see if they cause a reaction) for ragweed allergen
* Female participants must not be pregnant, lactating or be able to become pregnant
* Male participants must consent to use a medically acceptable method of contraception throughout the entire study period and for 3 months after the study is completed
* Participants with body mass index between 18 and 32 kilogram per square meter

Exclusion Criteria:

* Participants with clinically significant physical findings of nasal anatomical deformities
* Participants with a history of risk factors for torsades de pointes (heart failure, hypokalemia, family history of long QT syndrome), use of concomitant medications that prolong the QT or QTc interval or an abnormal 12-lead electrocardiogram except for clinically non-significant bradycardia
* Participants with history of exposure to an investigational treatment within the 30 days before the Screening Visit, or has ever taken JNJ-39220675 previously
* Participants with a history of clinically significant allergies, especially known hypersensitivity or intolerance to any drug or known allergy to the study drug or any of the excipients of the formulation
* Participants with a history of severe respiratory infection or disorder, epilepsy or seizures, coronary heart disease, uncontrolled hypertension, or other clinically significant cardiovascular disease, or history of a positive test for Human immuno-deficiency (HIV), Hepatitis B or Hepatitis C

Primary outcomes:
measure: Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry
timeFrame: 2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period
Secondary outcomes:
measure: Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)
timeFrame: 2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period
measure: Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period
measure: Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period
Other outcomes:
Locations:
city: Mississauga
country: Canada
state: Ontario
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
role: STUDY_DIRECTOR
References: