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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbomer 980 (1146A) | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbomer 980 (1146A) | Drug | Test product containing carbomer 980 gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) | 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. | Up to Day 4 (Day 1 to 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Nasal Symptom Score Over Days 1-7 (ANSS1-7) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Recent history (within the last 5 years) of alcohol or other substance abuse and positive urine drug screen.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35211 | United States | ||
| GSK Investigational Site |
A total of 308 participants were screened for this study, out of which137 participants were screening failure.
Participants were recruited from 24 centers in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A). |
| FG001 | Placebo Nasal Spray | Participants were administered placebo nasal spray containing vehicle without carbomer 980. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2017 | Apr 24, 2018 |
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| Placebo |
| Other |
Reference product containing vehicle without carbomer 980 gel |
|
| Up to Day 7 (Day 1 to 7) |
| Average Total Symptom Score Over Days 1-4 (ATSS1-4) | 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. | Up to Day 4 (Day 1 to 4) |
| Average Total Symptom Score Over Days 1-7 (ATSS1-7) | 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. | Up to Day 7 (Day 1 to 7) |
| Chandler |
| Arizona |
| 85224 |
| United States |
| GSK Investigational Site | Mesa | Arizona | 85206 | United States |
| GSK Investigational Site | Vista | California | 92083 | United States |
| GSK Investigational Site | Centennial | Colorado | 80112 | United States |
| GSK Investigational Site | Littleton | Colorado | 80128 | United States |
| GSK Investigational Site | Pinellas Park | Florida | 33781 | United States |
| GSK Investigational Site | Chicago | Illinois | 60602 | United States |
| GSK Investigational Site | Council Bluffs | Iowa | 51503 | United States |
| GSK Investigational Site | Edina | Minnesota | 55435 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Elkhorn | Nebraska | 68022 | United States |
| GSK Investigational Site | Fremont | Nebraska | 68025 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68144 | United States |
| GSK Investigational Site | Vineland | New Jersey | United States |
| GSK Investigational Site | Akron | Ohio | 44311 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45249 | United States |
| GSK Investigational Site | Hatboro | Pennsylvania | 19040 | United States |
| GSK Investigational Site | Anderson | South Carolina | 29621 | United States |
| GSK Investigational Site | Dallas | Texas | 75234 | United States |
| GSK Investigational Site | Plano | Texas | 75093 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Murray | Utah | 84123 | United States |
| GSK Investigational Site | Bellevue | Washington | 98004 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline parameters were reported for safety population. Safety population (N=168) included all randomized participants who received at least one dose of study medication.Three participants were randomized but not dosed, therefore not included in safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A). |
| BG001 | Placebo Nasal Spray | Participants were administered placebo nasal spray containing vehicle without carbomer 980. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Up to Day 4 (Day 1 to 4) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Nasal Symptom Score Over Days 1-7 (ANSS1-7) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Up to Day 7 (Day 1 to 7) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Total Symptom Score Over Days 1-4 (ATSS1-4) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Up to Day 4 (Day 1 to 4) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Total Symptom Score Over Days 1-7 (ATSS1-7) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Up to Day 7 (Day 1 to 7) |
|
Approximately 8 days
All treatment emergent adverse events and serious adverse were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product | Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A). | 0 | 87 | 1 | 87 | 32 | 87 |
| EG001 | Placebo Nasal Spray | Participants were administered placebo nasal spray containing vehicle without carbomer 980. | 0 | 81 | 0 | 81 | 34 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BIPOLAR DISORDER | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| SNEEZING | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| WHEEZING | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| INTRANASAL HYPOAESTHESIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| NASAL MUCOSAL EROSION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| NASAL MUCOSAL ULCER | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| RHINALGIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| HEADACHE | Nervous system disorders | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | Systematic Assessment |
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| BURNING SENSATION | Nervous system disorders | Systematic Assessment |
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| SINUS HEADACHE | Nervous system disorders | Systematic Assessment |
| ||
| SOMNOLENCE | Nervous system disorders | Systematic Assessment |
| ||
| ADMINISTRATION SITE PAIN | General disorders | Systematic Assessment |
| ||
| APPLICATION SITE PAIN | General disorders | Systematic Assessment |
| ||
| CHILLS | General disorders | Systematic Assessment |
| ||
| CHEST DISCOMFORT | General disorders | Systematic Assessment |
| ||
| FEELING COLD | General disorders | Systematic Assessment |
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| FEELING JITTERY | General disorders | Systematic Assessment |
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| PYREXIA | General disorders | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | Systematic Assessment |
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| RETCHING | Gastrointestinal disorders | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | Systematic Assessment |
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| ABSCESS OF EYELID | Infections and infestations | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | Systematic Assessment |
| ||
| LARYNGITIS | Infections and infestations | Systematic Assessment |
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| TOOTH INFECTION | Infections and infestations | Systematic Assessment |
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| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | Systematic Assessment |
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| BACK INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
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| EXCORIATION | Injury, poisoning and procedural complications | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| SEBORRHOEIC DERMATITIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | Systematic Assessment |
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| LACRIMATION INCREASED | Eye disorders | Systematic Assessment |
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| BLOOD PRESSURE SYSTOLIC INCREASED | Investigations | Systematic Assessment |
| ||
| PREGNANCY | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| PRODUCT TASTE ABNORMAL | Product Issues | Systematic Assessment |
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| BIPOLAR DISORDER | Psychiatric disorders | Systematic Assessment |
| ||
| POLLAKIURIA | Renal and urinary disorders | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 4, 2017 | Jun 11, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C479038 | carbomer |
Not provided
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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