A Pragmatic Randomised Trial of Ibuprofen, Paracetamol, Steam and Delayed Prescribing for Patients with Respiratory Tract Infections in Primary Care - Trial of ibuprofen, paracetamol, steam and delayed prescribing for RTI

Phase 1

• Conditions: Inclusion criteriaPatients 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 criteriaActive 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: 8.1Level: HLGTClassification code 10024970Term: Respiratory tract infections

• Registration Number: EUCTR2006-005740-83-GB
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-22
• Study Completion: 2013-12-03
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 889

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
(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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified