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

Early Phase 1

Completed

Conditions: Rhinitis, Allergic, Seasonal

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

Registration Number: NCT01500629

Lead Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C-1266-7	C-1266-6 (placebo)	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).
Placebo	C-1266-7	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.
C-1266-7	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).
Placebo	C-1266-6 (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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge	15 minutes (±5 minutes)	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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge	Within 1 hour	Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge	1 hour	The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour 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).
Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge	Within 1 hour	Change from baseline in number of sneezes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge	Within 1 hour	Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge	15 minutes	The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the second 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).
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge	Within 1 hour	The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the second 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).
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
Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge	Within 15 minutes	Change from baseline in number of sneezes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge	within 1 hour	Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge	Within 1 hour	Change from baseline in number of sneezes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge	Within 15 minutes	Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge	Within 15 minutes	Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge	within 1 hour	Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge	Within 15 minutes	Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge	within 15 minutes	Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge	within 1 hour	Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge	within 15 minutes	Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge	within 1 hour	Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge	within 15 minutes	A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.
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	within 15 minutes	TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge	Within 15 minutes	Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge	within 15 minutes	Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge	within 15 minutes	Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).
Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge	within 1 hour	Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).
Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge	within 15 minutes	Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge	within 1 hour	Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge	within 1 hour	A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge	within 1 hour	Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge	within 1 hour	Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).
Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge	within 15 minutes	A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.
Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge	within 1 hour	A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge	within 1 hour	Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge	within 15 minutes	Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
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	within 1 hour	TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge	within 15 minutes	Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge	within 15 minutes	Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge	within 1 hour	Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).
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	within 15 minutes	TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).
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	within 1 hour	TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).