Condition category
Respiratory
Date applied
14/01/2009
Date assigned
12/03/2009
Last edited
30/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Little

ORCID ID

Contact details

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)2380 241060
p.little@soton.ac.uk

Additional identifiers

EudraCT number

2006-005740-83

ClinicalTrials.gov number

Protocol/serial number

Protocol 4; 2006-005740-83

Study information

Scientific title

A pragmatic randomised trial of ibuprofen, paracetamol, steam and delayed prescribing for patients with respiratory tract infections in Primary Care

Acronym

PIPS

Study hypothesis

To assess, in a primary care setting, in patients with respiratory tract infection (RTI), whether:
1. There is a difference in the effectiveness between three 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

Ethics approval

Southampton and South West Hampshire REC (A) gave approval on the 12th January 2007 (ref: 06/Q1702/154)

Study design

3 x 2 x 2 randomised factorial controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Respiratory tract infection

Intervention

Patients will be randomised to receive one of three kinds of medication advice, one of two kinds of dosing advice and one of two kinds of steam advice.

1. Medication advice:
1.1. Paracetamol: participants will be advised to use paracetamol as their only antipyretic medication
1.2. Ibuprofen: participants will be advised to use ibuprofen as their only antipyretic medication
1.3. Combined paracetamol and ibuprofen: participants will be advised to use paracetamol and ibuprofen

2. Dosing advice:
2.1. Regular dosing: advice to take the medication(s) four times per day (irrespective of whether symptoms or fever have returned)
2.2. As required dosing: advice to take medication(s) as required by symptoms up to a maximum of four doses per day

3. Steam Advice:
3.1. Steam: subjects will be asked to inhale steam for 5 minutes, three times per day. Adults will be instructed to place a towel over their head over a bowl of recently boiled water. Children will be instructed to sit in a steamy room (made steamy by running a hot shower, or boiling a kettle in the room). Participants will receive written and verbal instructions at the beginning of the study.
3.2. No Steam: subjects will be asked not to use steam inhalation

Delayed prescription:
1. Patient led: the patient is given antibiotics and asked to wait to use them
2. Post-dating: the patient is given antibiotics, but post-dated
3. Collection: instructions to wait but can request antibiotics from front desk
4. Recontact/phone: patient is asked to contact/phone the surgery to leave message for doctor/nurse regarding a request for antibiotics, and able to come to reception

Intervention type

Drug

Phase

Not Applicable

Drug names

Ibuprofen, paracetamol

Primary outcome measures

Mean symptom severity during the first 3 days (as measured by symptom diary).

Secondary outcome measures

1. Side effects: the symptom diary will allow documentation of adverse events (e.g. rash, diarrhoea, vomiting, abdominal pain)
2. Health service resource use: the diary will document contacts with the health service - including NHS direct, the GP surgery and, secondary care - and any prescribed medication. The notes will be reviewed to confirm prescribed medication and contact with primary and secondary care.
3. Axillary temperature: axillary temperature will be measured by tempadot thermometer twice daily for three days

Overall trial start date

01/02/2009

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 3 years and over, either sex
2. Presenting to a General Practitioner (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)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

400 - 504

Participant exclusion criteria

1. Active or previous peptic ulceration
2. Hypersensitivity to aspirin ibuprofen or paracetamol
3. Inability to measure temperature or complete outcome measures (e.g. parents visually impaired, psychosis, severely depressed)
4. Patients requiring hospital admission (e.g. suspected meningitis, severe pneumonia, epiglottitis, Kawasaki's disease, etc.)
5. Patients with known immune deficiency (where the course of illness and symptomatic response might be modified)
6. Pregnancy or breastfeeding

Recruitment start date

01/02/2009

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

c/o Martina Prude
Legal Services - Research Governance Office
Highfield
Southampton
SO16 5ST
United Kingdom

Sponsor type

University/education

Website

http://www.soton.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) programme: PRIME Programme Grant (ref: RP-PG-0407-10098)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24162940
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24603565

Publication citations

  1. Results

    Little P, Moore M, Kelly J, Williamson I, Leydon G, McDermott L, Mullee M, Stuart B, , Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial., BMJ, 2013, 347, f6041.

  2. Results

    Little P, Moore M, Kelly J, Williamson I, Leydon G, McDermott L, Mullee M, Stuart B, , Delayed antibiotic prescribing strategies for respiratory tract infections in primary care: pragmatic, factorial, randomised controlled trial., BMJ, 2014, 348, g1606.

Additional files

Editorial Notes