E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10024970 |
E.1.2 | Term | Respiratory tract infections |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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).
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 will also be contacted by telephone at day 2-3 to check that there is no problem with completing the diary and to document over the phone the scores for that day in case the diary is not returned. This approach has been successful in previous studies of respiratory tract illness by our group which have achieved 80-90% follow-up.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last contact from the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |