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

NCT01500629 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-02-27

Study results available
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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.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    collaborator INDUSTRY

  • McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel S Qi, MD, PhD · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500629 on ClinicalTrials.gov