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Early Phase 1 N=21 Randomized Double-blind

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

Rhinitis, Allergic, Seasonal

Enrolled (actual)
21
Serious AEs
2.4%
Results posted
May 2014
Primary outcome: Primary: Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge — 2.90; 3.69 units on a scale — p=0.156

Study Design & Population

Study type
Interventional
Phase
Early Phase 1
Interventions
C-1266-7 (Device); C-1266-6 (placebo) (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Primary completion
Dec 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge
2.90; 3.69 0.156
SECONDARY
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge
.98; 1.27 0.625
SECONDARY
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge
2.73; 3.45 0.291
SECONDARY
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge
1.42; 1.49 0.899
SECONDARY
Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge
2.7; 2.1 0.701
SECONDARY
Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge
0.0; 0.2 0.108
SECONDARY
Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge
1.1; 1.2 0.253
SECONDARY
Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge
0.0; 0.1 0.287
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge
0.8; 1.1 0.409
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge
-0.1; 0.5 0.092
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge
0.3; 1.1 0.042 sig
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge
-0.0; 0.3 0.307
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge
0.4; 0.5 0.903
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge
0.2; 0.2 0.121
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge
0.5; 0.5 0.689
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge
0.4; 0.3 0.314
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge
0.8; 1.4 0.034 sig
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge
0.3; 0.3 0.845
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge
1.0; 1.1 0.619
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge
0.5; 0.5 0.803
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge
1.0; 0.8 0.175
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge
0.6; 0.4 0.206
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge
1.0; 0.8 0.072
SECONDARY
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge
0.6; 0.5 .0140 sig
SECONDARY
Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge
0.39; 0.40 0.907
SECONDARY
Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge
0.13; 0.18 0.666
SECONDARY
Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge
0.33; 0.34 0.972
SECONDARY
Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge
0.24; 0.10 0.521
SECONDARY
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge
0.46; 0.35 0.376
SECONDARY
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge
0.38; 0.29 0.350
SECONDARY
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge
0.42; 0.43 0.947
SECONDARY
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge
0.33; 0.39 0.651
SECONDARY
Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge
13
SECONDARY
Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge
10
SECONDARY
Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge
10
SECONDARY
Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge
6
SECONDARY
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
2.15; 2.61 0.261
SECONDARY
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
1.08; 0.82 0.481
SECONDARY
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
2.41; 2.39 0.961
SECONDARY
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
1.47; 1.24 0.546

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01500629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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