An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804687
• Other study ID #: CR015709
• Secondary ID: 39220675ATT2001
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2008
• Last updated: September 27, 2013
• Start date: November 2008
• Est. completion date: February 2009

Study information

• Verified date: September 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Other:
• Placebo
Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.

Drug:
• JNJ-39220675
Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
• Pseudoephedrine
Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry	The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.	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	No
Secondary	Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)	The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry).	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	No
Secondary	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	The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline.	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	No
Secondary	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	The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline.	Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period	No