Clinical trial NCT01500629: Study of a Topical Nasal Spray to Ease the Symptoms of Hayfever
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of a Topical Nasal Spray in the the Relief of Signs and Symptoms of an Acute Response to a Nasal Allergen Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Allergic Rhinitis
Hayfever
Pollen Allergy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Consumer and Personal Products Worldwide
First posted: 2011-12-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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.

Primary outcomes:
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge
timeFrame: 15 minutes (±5 minutes)
Secondary outcomes:
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge
timeFrame: 1 hour
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge
timeFrame: 15 minutes
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge
timeFrame: Within 1 hour
measure: Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge
timeFrame: Within 15 minutes
measure: Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge
timeFrame: Within 1 hour
measure: Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge
timeFrame: Within 15 minutes
measure: Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge
timeFrame: Within 1 hour
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge
timeFrame: Within 15 minutes
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge
timeFrame: Within 1 hour
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge
timeFrame: Within 15 minutes
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge
timeFrame: within 1 hour
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge
timeFrame: within 15 minutes
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge
timeFrame: within 1 hour
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge
timeFrame: Within 15 minutes
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge
timeFrame: Within 1 hour
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge
timeFrame: Within 15 minutes
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge
timeFrame: within 1 hour
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge
timeFrame: within 15 minutes
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge
timeFrame: within 1 hour
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge
timeFrame: within 15 minutes
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge
timeFrame: within 1 hour
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge
timeFrame: within 15 minutes
measure: Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge
timeFrame: within 1 hour
measure: Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge
timeFrame: within 15 minutes
measure: Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge
timeFrame: within 1 hour
measure: Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge
timeFrame: within 15 minutes
measure: Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge
timeFrame: within 1 hour
measure: Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge
timeFrame: within 15 minutes
measure: Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge
timeFrame: within 1 hour
measure: Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge
timeFrame: within 15 minutes
measure: Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge
timeFrame: within 1 hour
measure: Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge
timeFrame: within 15 minutes
measure: Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge
timeFrame: within 1 hour
measure: Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge
timeFrame: within 15 minutes
measure: Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge
timeFrame: within 1 hour
measure: Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the First Allergen Challenge
timeFrame: within 15 minutes
measure: Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the First Allergen Challenge
timeFrame: within 1 hour
measure: Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the Second Allergen Challenge
timeFrame: within 15 minutes
measure: Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the Second Allergen Challenge
timeFrame: within 1 hour
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
name: Daniel S Qi, MD, PhD
role: STUDY_DIRECTOR
References: