Study of a Topical Nasal Spray to Ease the Symptoms of Hayfever

NCT ID: NCT01500629

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study is to see if a new nasal spray can reduce the signs and symptoms of allergic rhinitis (hayfever). Subjects' participation in the study will last approximately 4 to 6 weeks, and each of three study visits during that time will last a few hours. Subjects will be required to have several tests done including allergy and breathing tests. They will be exposed to the item they are allergic to and will have small paper discs put in their noses. Subjects will also have the inside of their noses examined and will be asked questions about the level of their allergy symptoms.

Detailed Description

This study is a randomized, double blind, placebo-controlled, 2-way cross over trial. Approximately 25 subjects with a history of seasonal grass and/or ragweed allergy symptoms will be enrolled in the study to ensure 20 complete the study.

Subjects will be randomized to one of two treatment sequences of experimental product (investigational nasal spray) and placebo (sham nasal spray). Subjects will be asymptomatic of nasal symptoms (i.e., sneezing, itchy nose, runny nose, and nasal congestion) for at least 2 weeks prior to screening, and at least 1 week after the latest use of concomitant medication for symptom control in order to be eligible to participate in this study. Any subject with a history of mild asthma will be required to undergo a Forced Expiratory Volume in 1 second (FEV1) test prior to each nasal challenge (diluent and allergen) throughout the study. Assessments will be completed pre- and post-diluent challenge and post-allergen challenge. The baseline assessment for symptom scores is defined as the assessment obtained after the diluent challenge but prior (-15 minutes prior to randomization) to the administration of the experimental product/sham control.

Using a 14-day wash out period (± 2days), subjects who continue to meet inclusion criteria will receive treatments according to their randomized sequence. Eligible allergic subjects will undergo nasal challenges with either grass or ragweed allergen outside their allergy season.

Severity of symptoms will be assessed by the subject on a scale of 0=no symptoms to 3=severe. Adverse events will be collected during each visit, as well as the day following each visit via telephone.

Conditions

Rhinitis, Allergic, Seasonal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

C-1266-7

In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).

Group Type: EXPERIMENTAL

C-1266-7

Intervention Type: DEVICE

Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.

C-1266-6 (placebo)

Intervention Type: DEVICE

Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment.

Placebo

In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.

Group Type: EXPERIMENTAL

C-1266-7

Intervention Type: DEVICE

Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.

C-1266-6 (placebo)

Intervention Type: DEVICE

Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment.

Interventions

C-1266-7

Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.

Intervention Type: DEVICE

C-1266-6 (placebo)

Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment.

Intervention Type: DEVICE

Other Intervention Names

Not yet marketed; Not yet marketed

Eligibility Criteria

Inclusion Criteria

• History of grass and/or ragweed allergic rhinitis for at least 2 years prior to screening
• Positive skin test to grass and/or ragweed antigen within 12 months prior to screening
• Being asymptomatic of nasal symptoms (i.e., sneezing, itchy nose, runny nose, and nasal congestion) for at least 2 weeks prior to screening.
• Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to screening and agree to continue using it during participation in the study (abstinence is not an approved method).

Exclusion Criteria

• Participation in another investigational therapy 30 days prior to screening
• Not willing to give informed consent
• Inability to understand the nature and requirements of the study, or to comply with the study procedures
• Use of antihistamines within 1 week prior to screening (or during study visits)
• History of respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
• Current smoker or recent ex-smoker defined as history of smoking or use of nicotine containing substances within 2 months prior to screening as determined by medical history or subjects verbal report.
• Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: collaborator

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel S Qi, MD, PhD

Role: STUDY_DIRECTOR

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

POCEXP0001

Identifier Type: -

Identifier Source: org_study_id