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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary: 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.
Sponsor: GlaxoSmithKline

Current Primary Outcome: Average Nasal Symptom Score [ Time Frame: Day 1 - Day 4 ]

The nasal symptom score (NSS) will be calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). Each individual sign/symptom will be 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). The average nasal symptom score (ANSS) on days 1 to 4 is calculated as the mean of the 4 daily NSS across study days 1 to 4, excluding baseline NSS on Day 1.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Average Nasal Symptom Score [ Time Frame: Day 1 - Day 7 ]
    The nasal symptom score (NSS) will be calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). Each individual sign/symptom will be 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). The average nasal symptom score (ANSS) on days 1 to 7 is calculated as the mean of the 7 daily NSS across study days 1 to 7, excluding baseline NSS on Day 1.
  • Average Total Symptom Score [ Time Frame: Day 1- Day 4 and Day 1- Day 7 ]
    The total symptom scores (TSS) will be 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). Each individual sign/symptom will be 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). The ATSS on days 1 to 4 will be derived as the mean of all TSS across study Days 1 to 4 and the ATSS on days 1 to 7 will be derived as the mean of all TSS across Days 1 to 7.
  • Adverse events [ Time Frame: Day 1 - Day 7 ]
    Adverse and serious adverse events will be recorded.


Original Secondary Outcome:

  • Average Nasal Symptom Score [ Time Frame: Day 1 - Day 7 ]
    The nasal symptom score (NSS) will be calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). Each individual sign/symptom will be 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). The average nasal symptom score (ANSS) on days 1 to 7 is calculated as the mean of the 7 daily NSS across study days 1 to 7, excluding baseline NSS on Day 1.
  • Average Total Symptom Score [ Time Frame: Day 1- Day 4 and Day 1- Day 7 ]
    The total symptom scores (TSS) will be 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). Each individual sign/symptom will be 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). The ATSS on days 1 to 4 will be derived as the mean of all TSS across study Days 1 to 4 and the ATSS on days 1 to 7 will be derived as the mean of all TSS across Days 1 to 7.
  • Adverse events [ Time Frame: Day 1 - Day 7 ]
    Adverse and seroius adverse events will be recorded.


Information By: GlaxoSmithKline

Dates:
Date Received: December 7, 2016
Date Started: December 29, 2016
Date Completion: May 31, 2017
Last Updated: May 14, 2017
Last Verified: May 2017