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

NCT01500629 | Completed Early Phase 1 Results

• 1 other identifier: POCEXP0001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Allergic Rhinitis; Hayfever; Pollen Allergy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge

  The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).

  15 minutes (±5 minutes)

Secondary Outcomes (39)

• Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge

  1 hour

• Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge

  15 minutes

• Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge

  Within 1 hour

• Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge

  Within 15 minutes

• Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge

  Within 1 hour

Study Arms (2)

C-1266-7

EXPERIMENTAL

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).

Device: C-1266-7; Device: C-1266-6 (placebo)

Placebo

EXPERIMENTAL

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.

Device: C-1266-7; Device: C-1266-6 (placebo)

Interventions

C-1266-7 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.

Also known as: Not yet marketed

C-1266-7; Placebo

C-1266-6 (placebo) 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.

Also known as: Not yet marketed

C-1266-7; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.: lead
• Johnson & Johnson Consumer and Personal Products Worldwide: collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Daniel Qi, MD, PhD, Director, Clinical Research
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

dqi6@its.jnj.com

973 385-2260

Study Officials

• Daniel S Qi, MD, PhD

  McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 27, 2017
• Results First Posted: May 9, 2014

Record last verified: 2017-01

Locations

US (1)