Clinical trial NCT05556148
Conditions: Common Cold
Sponsor: HALEON
Start date: 2022-11-07; Completion date: 2022-12-20
Enrollment: 136 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to generate real world data from participants with nasal congestion acquired from common cold following treatment with a marketed nasal spray. The main purpose of this study is to evaluate the effectiveness of a nasal spray on quality of life (QoL) factors.

Detailed description:
This is a longitudinal, open-label study evaluating the effect on QoL factors in participants with the common cold using Otrivine nasal spray (xylometazoline hydrochloride 0.1 percent \[%\]), in a real-world setting. A sufficient number of adults aged 18 years and over with symptoms of common cold will be screened for eligibility. The study expects to enroll approximately 125 participants to ensure that 100 participants complete the study. All study data will be collected remotely through a study app using the participant's own mobile device.

Arms: arm 1: Participants will be instructed to use the product per label and leaflet instructions: 1 spray in each nostril up to 3 times per day until resolution of symptoms or up to a maximum of 7 days, whichever occurs first.
Interventions: intervention 1: Otrivine Congestion Relief
Intervention descriptions: intervention 1: 0.1% Nasal Spray (Xylometazoline Hydrochloride)

Protocol documents:
Prot_000.pdf: 
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this publicly available version
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218317 Protocol Amendment 07 Dec 20221TMF-24180711.0 
GSK Consumer Healthcare 
Clinical Protocol 
Protocol Number: 218317 
All eCRF pages should be completed during a subject assessment when the eCRF has been 
designated as the source. 
GSK CH will obtain and retain all eCRFs and associated study data as applicable at the 
completion of the study. 
Identifiable data are isolated to a special team at 
and these data will not be 
transferred/available to GSK CH. 
11.2 
Data Handling 
Documentation of all data management activities should allow step-by-step retrospective 
assessment of data quality and study performance. 
Any changes or corrections to data will be performed in the
Electronic Data 
Capture (EDC) Platform, and it will include rationale for changes. The EDC system has 
an audit trail, which will provide a complete record of the changes and corrections 
endorsed by the investigator/designee. 
Adverse events will be coded using Medical Dictionary for Regulatory Activities 
(MedDRA) and any concomitant medications terms (if applicable) using a validated 
medication dictionary, WHODrug. 
11.2.1 
Data Queries 
The
data management team will perform edit checks as the data are being 
entered into the system, and queries will be entered on a Data Issues Log for the 
decentralized site staff to address.
will raise queries as needed on safety data 
to code the terms (AEs and Drugs or concomitant medication) appropriately. 
The study monitor will perform ongoing review the of the eCRFs in accordance with the 
monitoring plan, to confirm that data entered into the eCRF by authorized site personnel 
are accurate, complete, and verifiable from source documents; that the safety and rights of 
subjects are being protected; and that the study is being conducted in accordance with the 
currently approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
11.3 
Processing Patient Reported Outcomes 
Electronic Patient reported outcome ( ePRO) data will be collected using electronic devices 
and transferred electronically to GSK CH or
All ePRO source data should be reviewed by the study staff and the study monitor to ensure 
accurate transcription of data and that any potential AEs or concomitant medications 
reported on these documents are discussed with the subject and transcribed accurately to 
the eCRF and/or OMS. ePROs that are classed as source data will be retained by the 
investigator and true/certified copies may be sent to a designated vendor or GSK CH as 
Property of GSK Consumer Healthcare - Confidential 
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
 Clinical Protocol Template v9.0 
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SAP_001.pdf: 
GSK-003 SAP
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STATISTICAL ANALYSIS PLAN
Sponsor:
Haleon
Protocol No.:
218317
Code:
GSK-003
Title: 
A Real-World Evidence Study Evaluating Quality of Life Parameters Following 
treatment with Otrivine (Xylometazoline hydrochloride)
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Contents
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE ..................................................................................4
1. ABBREVIATIONS.............................................................................................................................5
2. SCOPE............................................................................................................................................6
3. STUDY INTRODUCTION...................................................................................................................6
3.1
Study Background .............................................................................................................................6
3.2
Study Objectives ...............................................................................................................................7
3.2.1
Primary Objective ....................................................................................................................................7
3.2.2
Secondary Objective ................................................................................................................................7
3.2.3
Safety Objective.......................................................................................................................................7
3.3
Study Design......................................................................................................................................8
3.3.1
Study Population......................................................................................................................................8
3.3.2
Study Product/Treatment........................................................................................................................8
3.3.3
Study Period.............................................................................................................................................8
3.3.4
End of Study Definition............................................................................................................................8
4. STATISTICAL ANALYSIS ...................................................................................................................8
4.1
Sample Size Calculation ....................................................................................................................8
4.2
Endpoints ..........................................................................................................................................9
4.2.1
Primary Endpoints ...................................................................................................................................9
4.2.2
Secondary Endpoints ...............................................................................................................................9
4.2.3
Safety Endpoints......................................................................................................................................9
4.3
Analysis .............................................................................................................................................9
4.3.1
Population to be Analyzed.....................................................................................................................10
4.3.2
Demographics........................................................................................................................................10
4.3.3
Compliance ............................................................................................................................................10
4.3.4
Prior and Concomitant Medications......................................................................................................10
4.3.5
Medical History......................................................................................................................................10
4.3.6
Primary Objective Analysis ....................................................................................................................10
4.3.7
Secondary Objective Analysis ................................................................................................................11
4.3.8
Safety Objective Analysis.......................................................................................................................11
4.3.9
Exploratory Objective Analysis ..............................................................................................................11
4.3.10
Pot-Hoc Analyses ...................................................................................................................................11
4.3.11
Missing Values .......................................................................................................................................12
5. QUALITY CONTROL.......................................................................................................................12
5.1
Data and Output Quality Checks.....................................................................................................12
6. REPORTING..................................................................................................................................12
6.1
Clinical Study Report.......................................................................................................................13
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6.2
Statistical Analysis Outputs.............................................................................................................13
7. REVISION HISTORY .......................................................................................................................14
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Statistical Analysis Plan Signature Page 
We, the undersigned, have reviewed and approve this SAP, including the appendices.
                                                                                         
Name
Title
Signature
Date
   
                                                                                        
Name
Title
Signature
Date
.
Sponsor (Haleon)
Name
Title
Signature
Date
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1. Abbreviations
Abbreviation
Definition
ADS
Analysis Dataset
AE
Adverse Event
CSR
Clinical study report
eIC
Electronic Informed Consent
ITT
Intent To Treat
MedDRA
Medical dictionary for regulatory activities
mITT
Modified Intent To Treat
PT
Preferred Term
QoL
Quality of Life
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SD
Standard Deviation
SOC
System Organ Class
VAS
Visual Analogue Scale
WURSS
Wisconsin Upper Respiratory Symptom Survey
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2. Scope
This document describes the analysis plan for the statistical analysis of the study GSK-003, study 
explanation.
This Statistical Analysis Plan (SAP) will provide details to further elaborate statistical methods as outlined 
in the study protocol and describe the analysis conventions to guide the statistical programming work.
3. Study Introduction 
3.1
Study Background 
Otrivine (xylometazoline hydrochloride) is a nasal decongestant spray that constricts nasal blood vessels 
and increases nasal airflow, enabling individuals with a blocked nose to breathe more easily. This is a 
well-known and commonly used decongestant; different versions of this product have been marketed in 
numerous countries and used by consumers for decades. 
A double-blind, placebo-controlled, parallel group study by Eccles (Eccles et al., 2008) investigated the 
efficacy of the Otrivine nasal spray in patients with common cold.  Twenty-nine patients were treated 
with xylometazoline hydrochloride 0.1%, and 32 patients treated with a placebo (saline solution); 1 
spray 3 times a day for up to 10 days was the posology used. The primary objective of the study was to 
determine the decongestant effect (via nasal conductance); and the secondary objectives were to 
determine the peak subjective effects (visual analog scale), duration of relief of nasal congestion and 
total and individual cold symptoms.  In addition, any effects on sleep, tiredness, general well-being, and 
smell/taste were studied as exploratory variables with a daily diary, Adverse events (AEs) were also 
assessed. The decongestant effect of xylometazoline hydrochloride was significantly greater than 
placebo, as shown by the nasal conductance at 1 hour. Peak subjective effect (VAS assessment) was also 
significantly positive. Nasal conductance was significantly superior for up to 10 hours. Compared with 
placebo, xylometazoline hydrochloride significantly improved the total common cold symptom score on 
day 1 of treatment (xylometazoline hydrochloride 25.71 versus placebo 35.79; (p=0.0221)) and 
significantly improved individual common cold symptoms on day 1 (blocked nose, sore throat, and 
earache), day 2 (blocked nose), day 5 (runny nose), and day 10 (runny nose) of treatment. 
Xylometazoline hydrochloride-associated significant improvement of total and some individual common 
cold symptoms scores lead to significantly greater patient general evaluation and satisfaction with 
treatment. 
No differences were noted in the assessment of exploratory end points such as sleep, tiredness, daily 
activities, general well-being, and smell/taste. The study was neither designed nor powered to 
statistically evaluate these parameters. Nevertheless, most of the general assessment areas were rated 
significantly better with xylometazoline hydrochloride than with the placebo both on day 1 and on the 
last visit of the treatment period.
The authors concluded that xylometazoline hydrochloride is an effective and well-tolerated 
decongestant nasal spray that significantly relieved nasal congestion compared with placebo in the 
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common cold and provided long-lasting relief with just 1 spray - thereby helping patients to breathe 
more easily for a period of time. 
In the current study, GSK CH seeks to demonstrate that this level of congestion relief can provide a 
demonstrable improvement in QoL for those suffering from nasal congestion due to common cold. The 
specific goal of this study is to investigate the effect of Otrivine on QoL factors in adults with nasal 
congestion due to common cold. 
The common cold represents the most frequent human disease (Stein, 2017). Its most relevant 
definition is a common viral infection of the nose or throat, with symptoms such as sore throat, runny 
nose, sneezing, nasal congestion, clear discharge (mucus) from the nose, and body aches (Hemila, 2017). 
The trajectory of common cold symptoms caused by viruses can vary among individuals but does 
generally follow a familiar pattern. Cold symptoms tend to peak at 1 to 3 days after first appearance, 
thereafter symptoms usually last from 3 to 10 days. The mucus appearance may also change during this 
period. For some people the symptoms of common cold may linger a few more days, especially runny 
nose, stuffy nose, and coughing.
Nasal congestion and rhinorrhea are the most common complaints and start 1 to 2 days post infection 
and reach the maximum severity at days 2 to 3 (Eccles, 2005). 
Although common cold symptoms are usually mild, they represent a huge burden for society in terms of 
impaired QoL and economic losses (Passioti et al., 2014, Heikkinen and Jarvinen, 2003). While 
rhinoviruses are the predominant cause of the common cold, the aetiologic agent remains unknown in 
up to half of all upper respiratory tract infections (URTIs) (Stein, 2017). For the common cold, only 
symptomatic treatments exist (Passioti et al., 2014, Stein, 2017). Most people require no prescription 
medications or doctor visits but do use a variety of over-the-counter (OTC) medications for relief of 
symptoms.
3.2
Study Objectives
3.2.1
Primary Objective
To evaluate the over-time effects of Otrivine on QoL factors and common cold symptoms among 
individuals experiencing nasal congestion associated with common cold, following up to 7 days of 
treatment using WURSS-21.
3.2.2
Secondary Objective
To evaluate the over-time effects of Otrivine on additional measures of QoL factors among individuals 
experiencing nasal congestion associated with common cold, following up to 7 days of treatment, using 
additional QoL factors.
3.2.3
Safety Objective
To record adverse events (AEs) during study period.
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3.3
Study Design
3.3.1
Study Population
Adult subjects aged 18 years and over, displaying cold symptoms will be screened for enrollment into 
the study. It is anticipated that a total of 125 eligible subjects will be enrolled into the trial. This study 
assumes an approximate 20% drop out rate. A total of 100 subjects are expected to complete the study.
The common cold has an acute onset and limited duration. Hence subjects who have been displaying 
cold symptoms over no longer than the previous 24 hours will be further screened for eligibility and 
enrollment in the study. Subjects that confirm their common cold symptoms within 24 hours of 
receiving the study product will be enrolled into the study. Subjects who do not meet the eligibility 
criteria will be considered screen-fails and withdrawn from the study.
3.3.2
Study Product/Treatment
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride), Menthol (UK Marketplace).
3.3.3
Study Period
Given the natural course of the common cold, data collected during this study may be confounded by 
the natural resolution of the disease. Within 24 hours of cold onset, most patients report an escalation 
in the number of symptoms they experience, including sore throat, nasal congestion, runny nose, and 
headache. Over the initial days of having a cold, sore throat appears to be most bothersome on day 1 
followed by nasal congestion on days 2 to 5 and cough on days 6 and 7.
3.3.4
End of Study Definition
A subject is considered to have completed the study if they have completed all procedures and 
assessments of the study. 
Subjects will have the option to discontinue treatment at their discretion, if they determine they no 
longer want treatment. The end of this study per subject is tentatively defined as Day 7 but may vary 
based on the need/severity of nasal congestion.
4. Statistical Analysis
4.1
Sample Size Calculation
Sufficient individuals will be screened to enroll approximately 125 healthy eligible subjects assuming an 
estimated 20% drop out rate. It is believed that for this study 100 completed subjects are deemed 
sufficient to observe an improvement in QoL.
The sample size was based on a significance level ( ) = 0.05, Power (1- ) = 80%, and a standardized effect 
si
effect magnitude between 0.2 and 0.5 indicates mild improvement, between 0.5 and 0.8 indicates 
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moderate improvement, and greater than 0.8 indicates considerable improvement in symptoms and 
Literature review also indicated that QoL scores are not normally distributed. Subjects with worse baseline 
symptoms showed larger improvement in QoL scores. Therefore, a non-parametric Paired Wilcoxon 
sample size calculation was performed, using RStudio version 1.4.1103. 
Using the above parameters, we obtain a sample size N =125 eligible subjects to retain the required 100 
completed subjects.
4.2
Endpoints
4.2.1
Primary Endpoints
Scores over time on Days 0, 1, 2, 3, 4, 5, 6, 7 in: 
-
WURSS-21 total score: sum of questions 2 through 20
-
WURSS-21 total symptom domain: sum of questions 2 through 11
-
WURSS-21 total QoL domain: sum of questions 12 through 20
-
Each of the WURSS-21 symptom domains (10 in total): questions 2 through 11
4.2.2
Secondary Endpoints
Post-Otrivine use score on Days 1, 2, 3, 4, 5, 6, 7 for each of the following additional health related QoL 
factors:
-
snoring 
-
alertness the morning after
-
feeling self-conscious about how you sound
-
smell
-
taste
-
feeling self-conscious around people
-
energy 
-
motivation
4.2.3
Safety Endpoints
Number and percent of patients reporting AEs or serious AEs (SAEs) while on treatment. Number and 
percent of AEs and SAEs out of the total number of AEs/SAEs.
4.3
Analysis
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4.3.1
Population to be Analyzed
The enrolled population will include all subjects who meet the inclusion/exclusion criteria and have met 
the eligibility confirmation criteria.
The safety population will include all subjects who use study product at least once. Safety population will 
be used for safety variables. 
The modified Intent-To-Treat (mITT) population will include all subjects who use study product at least 
once and have data from at least one post baseline QoL questionnaire to support at least one of the 
primary endpoint assessments. QoL and ePRO data will be summarized using the mITT population only.
4.3.2
Demographics
Age and other continuous demographic and baseline variables will be summarized using descriptive 
statistics such as mean, range, median and standard deviation. Gender, race, ethnicity and other 
categorical demographic and baseline variables will be summarized using frequency counts and 
percentages for the safety and mITT populations.
4.3.3
Compliance
Study product compliance will be tabulated and summarized for the safety population.
Summaries will include a simple yes (up to 3 times a day)/no (more than 3 times a day)/Did not answer
frequency (and percent) count at each timepoint. The denominator for the percent will be those who 
answered the Cold Seeking Relief Questionnaire each day. Since the Cold Seeking Relief Questionnaire
Day 7 denominator 
4.3.4
Prior and Concomitant Medications
All concomitant medications will be coded using WHO Drug dictionary. 
Concomitant medications taken during the study will be summarized by WHO Drug Class and Preferred 
term as well as listed for the safety population.
4.3.5
Medical History
Medical History will be coded using MedDRA. Medical Histories will be summarized by System Organ 
Class (SOC) and Preferred Term (PT) listed for the safety population.
4.3.6
Primary Objective Analysis
For the primary objective, measurements of health related QoL indicators and cold symptoms will be 
evaluated using total score, QoL total domains score, total symptom domain scores and single symptom 
domain scores using the WURSS-21 questionnaire pre and post treatment to determine the effect of 
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Otrivine on QoL factors and cold symptoms. Change in mean WURSS-21 scores from pre and post 
-test. If data are 
found to be non-normal a non-parametric Hodges-Lehmann test will be used.
Mean, standard deviation, standard, error, median, minimum, and maximum will be presented by study 
day as well as end of treatment regardless of study day. Change from baseline will be depicted such that 
a negative difference shows an improvement in symptoms. P-values will be compared to a significance 
level at alpha = 0.05 and 95% confidence intervals will be presented. In summary, the data is significant 
when the p-value is less than the alpha level. 
4.3.7
Secondary Objective Analysis
-treatment score will be used to determine the effect of 
Otrivine on additional QoL parameters. Median post-treatment scores will be presented for each day of 
treatment through Day 7 or until data are no longer provided due to nasal symptom resolution.
The secondary objective will be analyzed in the same manner as the primary objective. 
4.3.8
Safety Objective Analysis
All AEs will be coded using MedDRA. The number of AEs/SAEs and number of subjects with AEs/SAEs will 
be tabulated by System Organ Class (SOC) and Preferred Term (PT).
AEs will be categorized as related, probable, unlikely, or unrelated by the local PI prior to database lock.
AEs categorized as related or probable will be considered 
and unlikely, or unrelated will be 
.  The number of related AEs/SAEs and number of subjects with 
AEs/SAEs will be tabulated by SOC and PT as well.
Adverse events will be listed individually with indic
time, severity, and relatedness to product.
4.3.9
Exploratory Objective Analysis
For the exploratory objective, time to resolution of symptoms will be evaluated using Kaplan-Meier curves 
of QoL factors. The median time to resolution of symptoms based on the Kaplan-Meier curve will be 
presented as well.
Additionally, a summary of the Individual WURSS-21 QoL Questions will be presented. The summary will
include the mean, standard deviation, standard error, median, minimum, and maximum by day. Answers 
to the final WURSS-21 question will be presented by counts and percent of participants.
4.3.10
Pot-Hoc Analyses
1)
WURSS-21 Individual QoL Questions will be analyzed in the same manner as the primary objective
analysis.
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2)
Additionally, Kaplan-Meier curves of WURSS Individual QoL responses and median time to resolution 
will be presented. 
3)
The Pearson Correlation Coefficient and p-value of the correlation between the WURSS-21 Plugged 
Nose symptom and the WURSS-21 Individual QoL responses (WURSS questions 12 through 20) and 
the 8 Individual additional Otrivin QoL responses.
4)
An analysis combining similar categories of the WURSS-21 responses (questions 1 -20) and the 8 
individual Otrivin QoL responses. The following categories will be analyzed in the same manner as the 
primary objective analysis.
Sleep quality: 
o
Sleep Well (WURSS-21 Q13)
o
Snoring (QoL Q1)
Physical activities: 
o
Breathe easily (WURSS-21 Q14)
o
Walk, climb stairs, exercise (WURSS-21 Q15)
o
Accomplish daily activities (WURSS-21 Q16)
Sensation: 
o
Sense of smell (QoL Q4)
o
Sense of taste (QoL Q5)
Vitality: 
o
Less energetic (QoL Q7)
o
Less motivated (QoL Q8)
o
Feel tired (WURSS-21 Q11)
o
Slow in response (QoL Q2)
Social: 
o
Interact with others (WURSS-21 Q19)  
o
Make you self-conscious around people (QoL Q6)
4.3.11
Missing Values
Missing values will not be imputed. 
5. Quality Control
5.1
Data and Output Quality Checks
Analysis related to the primary, secondary, safety, and exploratory objectives will be validated by a second 
biostatistician. 
All discrepancies identified during the output review will be corrected or documented until there are no 
findings, or findings could be explained. At the end of the study, all data sets used for analysis and final 
output will be archived.
6. Reporting
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6.1
Clinical Study Report
A Clinical Study Report (CSR) will be developed and provided by 
 after database lock, delivery 
of the statistical analysis, and the TLF deliverable is approved by the client. The report will address study 
background, methodology, and all required results including tables, listings, and figures agreed upon in 
the SAP.
6.2
Statistical Analysis Outputs
A Statistical Analysis Outputs will be developed and provided by 
 The report will include all 
required results in tables, listings, and figures agreed upon in the TLF Shells document. The Statistical 
Analysis Outputs will be output as either one file compiling all tables, listings, and figures, or a zip folder 
that houses the output items in separate files.
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7. Revision History
VERSION
EFFECTIVE DATE
CHANGES
1.0
27 January 2023
Original Document
2.0
14 March 2023
Added Post-Hoc Analyses
3.0
07 April 2023
Additional Post-Hoc Analysis item 4. Changed denominator for compliance 
4.0
117 April 2023
Updated clerical error in question numbers for Post-Hoc Analysis item 4.
5.0
30 November 2023
Corrected clerical error in Revision History for version line 4.0 on the year, 2023 
instead of 2024.
1 Date correction: Original Effective Date for this Statistical Analysis Plan is 17 April 2023; however, upon 
execution, a clerical error was noted on the year and instead of 2023, 2024 was referenced.  SAP has 
been re-routed on 30 November 2023 in order to correct this error. As this is a minor revision to only 
reflect the correct the year in the Revision History for version 4.0 and no other changes have been made 
to this, the SAP version is now 5.0 to reflect this correction being executed on 30 November 2023.
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