Inclusion criteria Patients aged 3 to 65 presenting to a GP or nurse with an RTI (acute cold, influenza, sore throat, otitis media, sinusitis, croup, or lower respiratory tract infection). Exclusion criteria Active or previous peptic ulceration, hypersensitivity to aspirin ibuprofen or paracetamol, inability to measure temperature or complete outcome measures, patients requiring hospital admission, patients with known immune deficiency, pregnancy or breastfeeding. MedDRA version: 8.1 Level: H
Conditions
Interventions
Product Name: Paracetamol
Pharmaceutical Form: Capsule*
INN or Proposed INN: Paracetamol
CAS Number: 103-90-2
Product Name: Ibuprofen
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ibuprofen
CAS
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Patients aged 3 to 65 presenting to a GP or nurse with an RTI diagnosed by the health professional (acute cold, influenza, sore throat, otitis media, sinusitis, croup, or lower respiratory tract infection). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria (i) active or previous peptic ulceration (ii) hypersensitivity to aspirin ibuprofen or paracetamol (iii) inability to measure temperature or complete outcome measures (e.g. parents visually impaired, psychosis, severely depressed) (iv) patients requiring hospital admission (e.g. suspected meningitis, severe pneumonia, epiglottitis, Kawasaki's disease etc), (v) patients with known immune deficiency (where the course of illness and symptomatic response might be modified) (vi) pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess, in a primary care setting, in patients with respiratory tract infection, whether: 1) there is a difference in the effectiveness between 3 different antipyretic regimes: ibuprofen treatment, paracetamol treatment and combined ibuprofen and paracetamol treatment 2) regular antipyretic dosing gives significantly better symptom and temperature control than 'as required' dosing 3) regular inhalation with steam further improves symptom control 4) there are any differences in antibiotic use and acceptability according to different methods of delaying antibiotic use ;Secondary Objective: i) Side effects The symptom diary will allow documentation of adverse events (e.g. rash, diarrhoea, vomiting, abdominal pain). (ii) Health service resource use The diary will document contacts with the health service. (iii) Axillary temperature Axillary temperature will be measured by tempadot thermometer twice daily for three days. (iv). Antibiotic use and other outcomes. As in our previous studies we will document both reported prescription use, whether prescriptions were collected by patients, how satisfied patients are using validated Likert scales(Little et al., 1997a; Little et al., 1997b) and how enabled they felt in managing their illness (Howie et al., 1999). ;Primary end point(s): The primary outcome is mean symptom severity during the first 3 days. Symptom severity will be measured using a symptom diary. We will use the diary items that we have used in several previous studies in the primary care setting (Little et al., 2001; Little et. al., 1997). Patients or parents will complete the symptom diary at the end of each day until symptoms have returned to normal. The principal outcome for symptoms will be the mean item score in the three days after randomisation, because this is the time when symptoms and temperature are rated most severe (Little et al., 2001; Little et. al., 1997; Watson et al., 2001). As in our previous studies they w | — |
Countries
United Kingdom
Outcome results
None listed