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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
171
Test product containing carbomer 980 gel
Reference product containing vehicle without carbomer 980 gel
GSK Investigational Site
Birmingham, Alabama, United States
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.
Time frame: Up to Day 4 (Day 1 to 4)
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.
Time frame: 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.
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GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Mesa, Arizona, United States
GSK Investigational Site
Vista, California, United States
GSK Investigational Site
Centennial, Colorado, United States
GSK Investigational Site
Littleton, Colorado, United States
GSK Investigational Site
Pinellas Park, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Council Bluffs, Iowa, United States
GSK Investigational Site
Edina, Minnesota, United States
...and 14 more locations
Time frame: 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.
Time frame: Up to Day 7 (Day 1 to 7)