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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: JNJ-39220675; Other: Placebo; Drug: Pseudoephedrine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804687

39220675ATT2001

CR015709

Details and patient eligibility

About

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).

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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53 participants in 6 patient groups

JNJ-39220675 then Pseudoephedrine then Placebo

Experimental group

Description:

Single-dose of JNJ-39220675 will be administered as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally along with placebo tablet in first treatment period; after that in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 milligram (mg) pseudoephedrine tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Treatment:

Other: Placebo

Drug: JNJ-39220675

Drug: Pseudoephedrine

JNJ-39220675 then Placebo then Pseudoephedrine

Experimental group

Description:

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Treatment:

Other: Placebo

Drug: JNJ-39220675

Drug: Pseudoephedrine

Placebo then JNJ-39220675 then Pseudoephedrine

Experimental group

Description:

Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Treatment:

Other: Placebo

Drug: JNJ-39220675

Drug: Pseudoephedrine

Placebo then Pseudoephedrine then JNJ-39220675

Experimental group

Description:

Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Treatment:

Other: Placebo

Drug: JNJ-39220675

Drug: Pseudoephedrine

Pseudoephedrine then JNJ-39220675 then Placebo

Experimental group

Description:

Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Treatment:

Other: Placebo

Drug: JNJ-39220675

Drug: Pseudoephedrine

Pseudoephedrine then Placebo then JNJ-39220675

Experimental group

Description:

Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Treatment:

Other: Placebo

Drug: JNJ-39220675

Drug: Pseudoephedrine