Clinical Trial: Effect of Paracetamol on the Common Cold

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: To Assess the Subjective Effect of Two Paracetamol Preparations on the Feeling of Breathing in Subjects With the Common Cold.

Brief Summary: The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Breathing Scores Post 15 Minutes [ Time Frame: Baseline to 15 minutes ]

A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. "my breathing feels easy", "I feel airways are open", "I feel a cooling sensation in my throat", "I can feel the air flowing to my lungs easily", "My nose feels less blocked" and "I feel my breathing is comfortable". The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.


Original Primary Outcome: Change from baseline in Visual Rating Scale Scores for Breathing Symptoms [ Time Frame: Baseline to 15 minutes post dose ]

Current Secondary Outcome:

  • Breathing Score Post 60 Minutes [ Time Frame: Baseline to 60 minutes ]
    A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. "my breathing feels easy", "I feel airways are open", "I feel a cooling sensation in my throat", "I can feel the air flowing to my lungs easily", "My nose feels less blocked" and "I feel my breathing is comfortable". The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
  • Cold Symptoms Score Post 15 Minutes [ Time Frame: Baseline to 15 minutes ]
    A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. "My head feels clear", "I feel soothing in my throat" and "I feel my cough is being soothed". The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
  • Cold Symptoms Score Post 60 Minutes [ Time Frame: Baseline to 60 minutes ]
    A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. "My head feels clear", "I feel soothing in my throat" and "I feel my cough is being soothed". The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
  • Soothing Attribute Scores [ Time Frame: Baseline to 15 and 60 minutes ]
    Soothing attribute of test treatment was assessed by asking the question "if the hot drink is soothing" at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'.
  • Overall Cold Symptoms Score [ Time Frame: Baseline to 15 and 60 minutes ]
    Overall cold symptom score was assessed by asking the question "my cold symptoms are improved" only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'.


Original Secondary Outcome:

  • Change from baseline in Visual Rating Scale Scores for Other Cold Symptoms [ Time Frame: Baseline to 15 minutes post dose ]
  • Change from baseline in Visual Rating Scale Scores for Breathing Symptoms [ Time Frame: Baseline to 60 minutes post dose ]


Information By: GlaxoSmithKline

Dates:
Date Received: January 12, 2011
Date Started: October 2010
Date Completion:
Last Updated: February 2, 2015
Last Verified: June 2013