Trial Outcomes & Findings for To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold (NCT NCT03005067)

Last Updated: 2018-06-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

171 participants

Primary outcome timeframe

Up to Day 4 (Day 1 to 4)

Results posted on

2018-06-19

Participant Flow

Participants were recruited from 24 centers in United States.

A total of 308 participants were screened for this study, out of which137 participants were screening failure.

Participant milestones

Participant milestones
Measure	Test Product Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Placebo Nasal Spray Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Overall Study STARTED	90	81
Overall Study COMPLETED	80	74
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Product Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Placebo Nasal Spray Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Overall Study Withdrawal by Subject	3	2
Overall Study Adverse Event	4	3
Overall Study Other (reason not specified)	3	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Product n=87 Participants Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Placebo Nasal Spray n=81 Participants Participants were administered placebo nasal spray containing vehicle without carbomer 980.	Total n=168 Participants Total of all reporting groups
Age, Continuous	49.8 Years STANDARD_DEVIATION 13.99 • n=99 Participants	50.3 Years STANDARD_DEVIATION 12.60 • n=107 Participants	50.1 Years STANDARD_DEVIATION 13.30 • n=206 Participants
Sex: Female, Male Female	57 Participants n=99 Participants	56 Participants n=107 Participants	113 Participants n=206 Participants
Sex: Female, Male Male	30 Participants n=99 Participants	25 Participants n=107 Participants	55 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	35 Participants n=99 Participants	28 Participants n=107 Participants	63 Participants n=206 Participants
Race (NIH/OMB) White	51 Participants n=99 Participants	53 Participants n=107 Participants	104 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: Up to Day 4 (Day 1 to 4)

Population: 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.

Outcome measures

Outcome measures
Measure	Test Product n=86 Participants Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Placebo Nasal Spray n=79 Participants Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)	3.428 Score on a scale Standard Deviation 1.4784	3.336 Score on a scale Standard Deviation 1.6917

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Product n=86 Participants Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Placebo Nasal Spray n=79 Participants Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)	2.700 Score on a scale Standard Deviation 1.3142	2.651 Score on a scale Standard Deviation 1.5455

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Product n=86 Participants Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Placebo Nasal Spray n=79 Participants Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Average Total Symptom Score Over Days 1-4 (ATSS1-4)	7.811 Score on a scale Standard Deviation 3.1962	7.754 Score on a scale Standard Deviation 3.4996

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Product n=86 Participants Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Placebo Nasal Spray n=79 Participants Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Average Total Symptom Score Over Days 1-7 (ATSS1-7)	6.171 Score on a scale Standard Deviation 2.9822	6.195 Score on a scale Standard Deviation 3.2078

Adverse Events

Test Product

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo Nasal Spray

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Product n=87 participants at risk Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Placebo Nasal Spray n=81 participants at risk Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Psychiatric disorders BIPOLAR DISORDER	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Test Product n=87 participants at risk Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).	Placebo Nasal Spray n=81 participants at risk Participants were administered placebo nasal spray containing vehicle without carbomer 980.
Respiratory, thoracic and mediastinal disorders COUGH	5.7% 5/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	2.3% 2/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	4.9% 4/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	3.4% 3/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	2.5% 2/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	3.4% 3/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	2.5% 2/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	4.6% 4/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders SNEEZING	3.4% 3/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	2.5% 2/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders NASAL DRYNESS	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	3.7% 3/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders WHEEZING	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	2.5% 2/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders NASAL DISCOMFORT	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	2.5% 2/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders INTRANASAL HYPOAESTHESIA	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders NASAL MUCOSAL EROSION	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders NASAL MUCOSAL ULCER	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Respiratory, thoracic and mediastinal disorders RHINALGIA	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Nervous system disorders HEADACHE	9.2% 8/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	7.4% 6/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Nervous system disorders DIZZINESS	2.3% 2/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Nervous system disorders BURNING SENSATION	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Nervous system disorders SINUS HEADACHE	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Nervous system disorders SOMNOLENCE	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
General disorders ADMINISTRATION SITE PAIN	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	3.7% 3/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
General disorders APPLICATION SITE PAIN	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	2.5% 2/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
General disorders CHILLS	2.3% 2/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
General disorders CHEST DISCOMFORT	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
General disorders FEELING COLD	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
General disorders FEELING JITTERY	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
General disorders PYREXIA	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Musculoskeletal and connective tissue disorders MYALGIA	5.7% 5/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	4.9% 4/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Musculoskeletal and connective tissue disorders NECK PAIN	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Gastrointestinal disorders NAUSEA	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	2.5% 2/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Gastrointestinal disorders DRY MOUTH	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Gastrointestinal disorders RETCHING	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Gastrointestinal disorders VOMITING	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Infections and infestations ABSCESS OF EYELID	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Infections and infestations BRONCHITIS	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Infections and infestations LARYNGITIS	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Infections and infestations TOOTH INFECTION	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Infections and infestations VULVOVAGINAL MYCOTIC INFECTION	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Injury, poisoning and procedural complications BACK INJURY	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Injury, poisoning and procedural complications EXCORIATION	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Skin and subcutaneous tissue disorders SEBORRHOEIC DERMATITIS	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Ear and labyrinth disorders VERTIGO	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Eye disorders LACRIMATION INCREASED	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Investigations BLOOD PRESSURE SYSTOLIC INCREASED	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Pregnancy, puerperium and perinatal conditions PREGNANCY	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Product Issues PRODUCT TASTE ABNORMAL	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Psychiatric disorders BIPOLAR DISORDER	1.1% 1/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	0.00% 0/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Renal and urinary disorders POLLAKIURIA	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.
Vascular disorders HYPERTENSION	0.00% 0/87 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.	1.2% 1/81 • Approximately 8 days All treatment emergent adverse events and serious adverse were reported.