To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03005067
• Collaborator: (none)
• Enrollment: 171
• Locations: 24
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site: 7.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This study will be conducted in adult participants with symptoms of common cold assessing if 1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo. The study will also evaluate the safety of 1146A compared to placebo.

Condition or Disease	Intervention/Treatment	Phase
Common Cold	Drug: Carbomer 980 (1146A); Other: Placebo	Phase 2

Detailed Description

This will be a multi-center, randomized, parallel-group, double blind, 2-arm, placebo controlled study to evaluate the efficacy and safety of 1146A in adult participants with symptomatic common cold in an outpatient setting.

Study Design

• Study Type: Interventional
• Actual Enrollment: 171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Subjects With Symptoms of Common Cold
• Actual Study Start Date: Dec 29, 2016
• Actual Primary Completion Date: Jun 7, 2017
• Actual Study Completion Date: Jun 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carbomer 980 (1146A) Participants will be administered test product (nasal spray) containing carbomer 980 gel. Three actuations per nostril per dose will be applied, each actuation will be 140µL (microliters) i.e. equivalent to 140mg.	Drug: Carbomer 980 (1146A); Test product containing carbomer 980 gel
Placebo Comparator: Placebo Participants will be administered reference product (nasal spray) containing vehicle without carbomer 980. Three actuations of placebo nasal spray per nostril per dose; each actuation will be 140µL.	Other: Placebo; Reference product containing vehicle without carbomer 980 gel

Outcome Measures

Primary Outcome Measures

1. Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) [Up to Day 4 (Day 1 to 4)]

   The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.

Secondary Outcome Measures

1. Average Nasal Symptom Score Over Days 1-7 (ANSS1-7) [Up to Day 7 (Day 1 to 7)]

   The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.

2. Average Total Symptom Score Over Days 1-4 (ATSS1-4) [Up to Day 4 (Day 1 to 4)]

   The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.

3. Average Total Symptom Score Over Days 1-7 (ATSS1-7) [Up to Day 7 (Day 1 to 7)]

   The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

• Aged between 18 to 75 years inclusive.

• Male or female.

• Good general and mental health with, in the opinion of the Investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical and Investigator-led nasal examination.

• Females of childbearing potential who are, in the opinion of the Investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal agent (foam, gel, film, cream, suppository)) OR male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant.

• Investigator confirmed diagnosis of symptomatic common cold with an onset of less than 48 hours prior to randomization. Symptomatic common cold is defined as TSS > 9 AND a score >1 for at least one of the following symptoms: sore throat, runny nose, or blocked nose.

Exclusion Criteria:

• Women who have a positive urine pregnancy test.

• Women who are breast-feeding.

• During the entire study (Screening - last participant visit):

• 1. Participant who have used medications or therapies that could interfere with study evaluations and have not had the proper washout period from these medications or therapies or are anticipated to require any concomitant intranasal medication during that period or at any time throughout the study.
• 1. Nasal disease(s) likely to affect deposition of intranasal medication, such as chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities.
• 1. Nasal surgery or sinus surgery within the previous year.
• 1. Any condition that prohibits the participant from actuating nasal spray devices (severe rheumatoid arthritis; deformed hands and fingers; missing fingers).
• 1. Clinically relevant abnormal physical findings which, in the opinion of the Investigator or sponsor's medical monitor, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
• 1. Uncontrolled cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrine, metabolic, autoimmune, neurological, psychiatric or other diseases at screening that would interfere with the study in the opinion of the Investigator.
• 1. Participants with seasonal allergic rhinitis if randomization occurs during their expected allergy season or perennial allergic rhinitis.
• 1. Severe COPD, persistent asthma, or recent COPD/asthma exacerbation.
• 1. An inability to comprehend and satisfactorily use the measurement instruments as determined by the study sites staff on screening.
• 1. Participants with a fever > 38°C (100.4°F).
• 1. Frequent uses of analgesics (i.e. have taken an analgesic for pain in headache and pain in muscle/joints for at least 1 dose per week on average over the past 6 months).

• Known or suspected intolerance or hypersensitivity to any of the study medications, excipients or investigational device material or to medications of similar chemical classes, any history of drug hypersensitivity or other significant allergic diathesis that could affect study participation and known or suspected contraindications, including history of allergy or photosensitivity to study medication/s.

• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit or 5 half-lives of enrollment, whichever is longer and previous participation in this study (i.e. participants cannot be re-screened or randomized).

Recent history (within the last 5 years) of alcohol or other substance abuse and positive urine drug screen.

• An employee of the sponsor or the study sites or members of their immediate family and persons directly or indirectly involved in the execution of this protocol, including employees of the contract research organization (CRO) and persons related to them.

• On nasal examination by Investigator, the presence of nasal disease likely to affect deposition of intranasal treatment or any superficial or moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation at the screening visit. Participants with difficulty in using the nasal spray applicator, "vulnerable" individual (as defined by the IRB e.g. incarcerated person) and any condition not identified in the protocol that in the opinion of the Investigator would confound the evaluation and interpretation of the study data or may put the participant at risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35211
2	GSK Investigational Site	Chandler	Arizona	United States	85224
3	GSK Investigational Site	Mesa	Arizona	United States	85206
4	GSK Investigational Site	Vista	California	United States	92083
5	GSK Investigational Site	Centennial	Colorado	United States	80112
6	GSK Investigational Site	Littleton	Colorado	United States	80128
7	GSK Investigational Site	Pinellas Park	Florida	United States	33781
8	GSK Investigational Site	Chicago	Illinois	United States	60602
9	GSK Investigational Site	Council Bluffs	Iowa	United States	51503
10	GSK Investigational Site	Edina	Minnesota	United States	55435
11	GSK Investigational Site	Saint Louis	Missouri	United States	63141
12	GSK Investigational Site	Elkhorn	Nebraska	United States	68022
13	GSK Investigational Site	Fremont	Nebraska	United States	68025
14	GSK Investigational Site	Omaha	Nebraska	United States	68144
15	GSK Investigational Site	Vineland	New Jersey	United States
16	GSK Investigational Site	Akron	Ohio	United States	44311
17	GSK Investigational Site	Cincinnati	Ohio	United States	45249
18	GSK Investigational Site	Hatboro	Pennsylvania	United States	19040
19	GSK Investigational Site	Anderson	South Carolina	United States	29621
20	GSK Investigational Site	Dallas	Texas	United States	75234
21	GSK Investigational Site	Plano	Texas	United States	75093
22	GSK Investigational Site	San Antonio	Texas	United States	78229
23	GSK Investigational Site	Murray	Utah	United States	84123
24	GSK Investigational Site	Bellevue	Washington	United States	98004

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - May 19, 2017
• Statistical Analysis Plan - Aug 4, 2017

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03005067
• Other Study ID Numbers: 205684
• First Posted: Dec 29, 2016
• Last Update Posted: Jun 19, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Common Cold

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 24 centers in United States.
Pre-assignment Detail	A total of 308 participants were screened for this study, out of which137 participants were screening failure.

Arm/Group Title	Test Product	Placebo Nasal Spray
Arm/Group Description	Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Period Title: Overall Study
STARTED	90	81
COMPLETED	80	74
NOT COMPLETED	10	7

Baseline Characteristics

Arm/Group Title	Test Product	Placebo Nasal Spray	Total
Arm/Group Description	Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Participants were administered placebo nasal spray containing vehicle without carbomer 980.	Total of all reporting groups
Overall Participants	87	81	168
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.8 (13.99)	50.3 (12.60)	50.1 (13.30)
Sex: Female, Male (Count of Participants)
Female	57 65.5%	56 69.1%	113 67.3%
Male	30 34.5%	25 30.9%	55 32.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.1%	0 0%	1 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	35 40.2%	28 34.6%	63 37.5%
White	51 58.6%	53 65.4%	104 61.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)
Description	The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.
Time Frame	Up to Day 4 (Day 1 to 4)

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.

Arm/Group Title	Test Product	Placebo Nasal Spray
Arm/Group Description	Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Measure Participants	86	79
Mean (Standard Deviation) [Score on a scale]	3.428 (1.4784)	3.336 (1.6917)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Placebo Nasal Spray
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.516
	Comments	P-value was based on the Wald statistic Chi-Square test, from an ANCOVA model with treatment, center, and Day 1 dosing time stratification as factors and baseline NSS (Day 1 prior to the first dose) as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.137
	Confidence Interval	(2-Sided) 95%; -0.279 to 0.553
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference of LS mean is 1146A Formulation Nasal Spray - Placebo Nasal Spray. 95% CI is for difference of LS means.

2. Secondary Outcome

Title	Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)
Description	The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.
Time Frame	Up to Day 7 (Day 1 to 7)

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.

Arm/Group Title	Test Product	Placebo Nasal Spray
Arm/Group Description	Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Measure Participants	86	79
Mean (Standard Deviation) [Score on a scale]	2.700 (1.3142)	2.651 (1.5455)

3. Secondary Outcome

Title	Average Total Symptom Score Over Days 1-4 (ATSS1-4)
Description	The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.
Time Frame	Up to Day 4 (Day 1 to 4)

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.

Arm/Group Title	Test Product	Placebo Nasal Spray
Arm/Group Description	Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Measure Participants	86	79
Mean (Standard Deviation) [Score on a scale]	7.811 (3.1962)	7.754 (3.4996)

4. Secondary Outcome

Title	Average Total Symptom Score Over Days 1-7 (ATSS1-7)
Description	The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.
Time Frame	Up to Day 7 (Day 1 to 7)

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.

Arm/Group Title	Test Product	Placebo Nasal Spray
Arm/Group Description	Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Measure Participants	86	79
Mean (Standard Deviation) [Score on a scale]	6.171 (2.9822)	6.195 (3.2078)

Adverse Events

Time Frame	Approximately 8 days
Adverse Event Reporting Description	All treatment emergent adverse events and serious adverse were reported.
Arm/Group Title	Test Product		Placebo Nasal Spray
Arm/Group Description	Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).		Participants were administered placebo nasal spray containing vehicle without carbomer 980.
All Cause Mortality
	Test Product		Placebo Nasal Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/81 (0%)
Serious Adverse Events
	Test Product		Placebo Nasal Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/87 (1.1%)		0/81 (0%)
Psychiatric disorders
BIPOLAR DISORDER	1/87 (1.1%)		0/81 (0%)
Other (Not Including Serious) Adverse Events
	Test Product		Placebo Nasal Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/87 (36.8%)		34/81 (42%)
Ear and labyrinth disorders
VERTIGO	0/87 (0%)		1/81 (1.2%)
Eye disorders
LACRIMATION INCREASED	1/87 (1.1%)		0/81 (0%)
Gastrointestinal disorders
NAUSEA	1/87 (1.1%)		2/81 (2.5%)
DRY MOUTH	1/87 (1.1%)		0/81 (0%)
RETCHING	1/87 (1.1%)		0/81 (0%)
VOMITING	0/87 (0%)		1/81 (1.2%)
General disorders
ADMINISTRATION SITE PAIN	0/87 (0%)		3/81 (3.7%)
APPLICATION SITE PAIN	1/87 (1.1%)		2/81 (2.5%)
CHILLS	2/87 (2.3%)		1/81 (1.2%)
CHEST DISCOMFORT	1/87 (1.1%)		0/81 (0%)
FEELING COLD	1/87 (1.1%)		0/81 (0%)
FEELING JITTERY	0/87 (0%)		1/81 (1.2%)
PYREXIA	0/87 (0%)		1/81 (1.2%)
Infections and infestations
ABSCESS OF EYELID	1/87 (1.1%)		0/81 (0%)
BRONCHITIS	0/87 (0%)		1/81 (1.2%)
LARYNGITIS	0/87 (0%)		1/81 (1.2%)
TOOTH INFECTION	0/87 (0%)		1/81 (1.2%)
VULVOVAGINAL MYCOTIC INFECTION	1/87 (1.1%)		0/81 (0%)
Injury, poisoning and procedural complications
BACK INJURY	1/87 (1.1%)		0/81 (0%)
EXCORIATION	0/87 (0%)		1/81 (1.2%)
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED	0/87 (0%)		1/81 (1.2%)
Musculoskeletal and connective tissue disorders
MYALGIA	5/87 (5.7%)		4/81 (4.9%)
ARTHRALGIA	1/87 (1.1%)		0/81 (0%)
BACK PAIN	0/87 (0%)		1/81 (1.2%)
NECK PAIN	1/87 (1.1%)		0/81 (0%)
Nervous system disorders
HEADACHE	8/87 (9.2%)		6/81 (7.4%)
DIZZINESS	2/87 (2.3%)		0/81 (0%)
BURNING SENSATION	0/87 (0%)		1/81 (1.2%)
SINUS HEADACHE	1/87 (1.1%)		0/81 (0%)
SOMNOLENCE	1/87 (1.1%)		0/81 (0%)
Pregnancy, puerperium and perinatal conditions
PREGNANCY	0/87 (0%)		1/81 (1.2%)
Product Issues
PRODUCT TASTE ABNORMAL	0/87 (0%)		1/81 (1.2%)
Psychiatric disorders
BIPOLAR DISORDER	1/87 (1.1%)		0/81 (0%)
Renal and urinary disorders
POLLAKIURIA	0/87 (0%)		1/81 (1.2%)
Respiratory, thoracic and mediastinal disorders
COUGH	5/87 (5.7%)		1/81 (1.2%)
EPISTAXIS	2/87 (2.3%)		4/81 (4.9%)
NASAL CONGESTION	3/87 (3.4%)		2/81 (2.5%)
OROPHARYNGEAL PAIN	3/87 (3.4%)		2/81 (2.5%)
RHINORRHOEA	4/87 (4.6%)		1/81 (1.2%)
SNEEZING	3/87 (3.4%)		2/81 (2.5%)
NASAL DRYNESS	0/87 (0%)		3/81 (3.7%)
WHEEZING	1/87 (1.1%)		2/81 (2.5%)
NASAL DISCOMFORT	0/87 (0%)		2/81 (2.5%)
DYSPNOEA	1/87 (1.1%)		0/81 (0%)
INTRANASAL HYPOAESTHESIA	1/87 (1.1%)		0/81 (0%)
NASAL MUCOSAL EROSION	0/87 (0%)		1/81 (1.2%)
NASAL MUCOSAL ULCER	1/87 (1.1%)		0/81 (0%)
RHINALGIA	0/87 (0%)		1/81 (1.2%)
Skin and subcutaneous tissue disorders
PRURITUS	0/87 (0%)		1/81 (1.2%)
SEBORRHOEIC DERMATITIS	0/87 (0%)		1/81 (1.2%)
Vascular disorders
HYPERTENSION	0/87 (0%)		1/81 (1.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.