Rhinitis, Allergic, SeasonalEarly Phase 1NCT01500629

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

A Early Phase 1 study testing C-1266-7 in people with Rhinitis, Allergic, Seasonal, run by McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Rhinitis, Allergic, Seasonal
What is being tested?: C-1266-7
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Dec 2012
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Rhinitis, Allergic, Seasonal
Being tested: C-1266-7, C-1266-6 (placebo)
Keywords: Allergic Rhinitis, Hayfever, Pollen Allergy
Medical subject headings: Rhinitis, Allergic, Seasonal, Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

C-1266-7Device
Also called Not yet marketed
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.
C-1266-6 (placebo)Device
Also called Not yet marketed
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.

Study groups in NCT01500629
Study group	Role	What they receive
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). Receives: 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. Receives: Device: C-1266-7; Device: C-1266-6 (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
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).
Measured: 1 hour
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge
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).
Measured: 15 minutes
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge
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).
Measured: Within 1 hour
Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge
Change from baseline in number of sneezes
Measured: Within 15 minutes
Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge
Change from baseline in number of sneezes
Measured: Within 1 hour
Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge
Change from baseline in number of sneezes
Measured: Within 15 minutes
Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge
Change from baseline in number of sneezes
Measured: Within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge
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).
Measured: Within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge
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).
Measured: Within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge
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).
Measured: Within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge
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).
Measured: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge
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).
Measured: within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge
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).
Measured: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge
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).
Measured: Within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge
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).
Measured: Within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge
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).
Measured: Within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge
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).
Measured: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge
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).
Measured: within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge
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).
Measured: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge
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).
Measured: within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge
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).
Measured: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge
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).
Measured: within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge
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).
Measured: within 1 hour
Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge
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).
Measured: within 15 minutes
Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge
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).
Measured: within 1 hour
Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge
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).
Measured: within 15 minutes
Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge
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).
Measured: within 1 hour
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge
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).
Measured: within 15 minutes
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge
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).
Measured: within 1 hour
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge
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).
Measured: within 15 minutes
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge
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).
Measured: within 1 hour
Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge
A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.
Measured: within 15 minutes
Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge
A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.
Measured: within 1 hour
Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge
A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.
Measured: within 15 minutes
Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge
A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.
Measured: within 1 hour
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
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).
Measured: within 15 minutes
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
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).
Measured: within 1 hour
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
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).
Measured: within 15 minutes
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
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).
Measured: within 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Dec 2012

First posted28 Dec 2011 (estimated)
Study startJan 2012
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01500629
Sponsor's protocol ID: POCEXP0001
Status last verified: Jan 2017
First submitted: 22 Dec 2011
Last updated: 27 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rhinitis, Allergic, Seasonal trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01500629
Acronym / sponsor ID: POCEXP0001
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Allergic Rhinitis, Hayfever, Pollen Allergy
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
Collaborators: Johnson & Johnson Consumer and Personal Products Worldwide
Study start: Jan 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 28 Dec 2011 (estimated)
Results: Posted 9 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
C-1266-7	Experimental	Device: C-1266-7, Device: 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	Experimental	Device: C-1266-7, Device: 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
C-1266-7Also: Not yet marketedEach 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-1266-7, Placebo
C-1266-6 (placebo)Also: Not yet marketedEach 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.	Device	C-1266-7, Placebo

Primary outcome

Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge
Time frame: 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).

39 secondary outcomes

Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge
Time frame: 1 hour
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge
Time frame: 15 minutes
Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge
Time frame: Within 1 hour
Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge
Time frame: Within 15 minutes
Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge
Time frame: Within 1 hour
Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge
Time frame: Within 15 minutes
Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge
Time frame: Within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge
Time frame: Within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge
Time frame: Within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge
Time frame: Within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge
Time frame: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge
Time frame: within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge
Time frame: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge
Time frame: Within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge
Time frame: Within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge
Time frame: Within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge
Time frame: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge
Time frame: within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge
Time frame: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge
Time frame: within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge
Time frame: within 1 hour
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge
Time frame: within 15 minutes
Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge
Time frame: within 1 hour
Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge
Time frame: within 15 minutes
Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge
Time frame: within 1 hour
Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge
Time frame: within 15 minutes
Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge
Time frame: within 1 hour
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge
Time frame: within 15 minutes
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge
Time frame: within 1 hour
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge
Time frame: within 15 minutes
Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge
Time frame: within 1 hour
Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge
Time frame: within 15 minutes
Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge
Time frame: within 1 hour
Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge
Time frame: within 15 minutes
Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge
Time frame: within 1 hour
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
Time frame: within 15 minutes
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
Time frame: within 1 hour
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
Time frame: within 15 minutes
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
Time frame: within 1 hour

Results and safety

Results posted to the registry on 9 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
C-1266-7 Then Placebo	11	11
Placebo Then C-1266-7	10	10

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

Time frame: 15 minutes (±5 minutes). Mean (Standard Error). Unit: units on a scale

Measure	C-1266-7 n = 21	Placebo n = 20
Value	2.90 (0.533)	3.69 (0.542)

C-1266-7 vs Placebo: Mean Difference (Final Values): -0.79 (95% CI -1.90 to 0.33), p = 0.156, Mixed Models Analysis

Population analysed: Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.

39 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 63 days (+30 days for Serious Adverse Events). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
C-1266-7	1 of 21 (4.8%)	1 of 21 (4.8%)	Not reported
Placebo	0 of 20 (0%)	2 of 20 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel S Qi, MD, PhD study director

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing C-1266-7 in people with Rhinitis, Allergic, Seasonal, run by McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge (time frame: 15 minutes (±5 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01500629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.