Better treatment for acute sinusitis in primary care

Phase 1

• Conditions: Acute rhinosinusitis; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2020-000429-17-NO
• Lead Sponsor: niversity of Oslo, Faculty of Medicine, Institute of Health and Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-14
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1.Participant is willing and able to give informed consent for participation in the trial. This will include the ability to understand the study information in Norwegian.
2.Male or Female, aged 18 – 64 years.
3.Diagnosed by their GP with probable acute sinusitis, according to usual diagnostic criteria used by the GP, and according to Norwegian guidelines.
4.In the Investigator’s opinion, is able and willing to comply with all trial requirements.

Are the trial subjects under 18? no
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 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Chronic sinusitis; symptoms of the current infection must not exceed four weeks. Participants with recurrent sinusitis are eligible, provided they are symptom free between episodes of sinusitis.
2.Patients having had previous sinus surgery. Patients having had only rhinosurgery are eligible.
3.Significant renal or hepatic impairment.
4.Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
5.Participant with life expectancy of less than 6 months.
6.Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
7.Patients with any of the following eye conditions:
oEye injury, eye surgery or laser treatment in the previous 6 months
oRecurrent bacterial conjunctivitis (more than 2 episodes last 2 years)
oChronic ongoing eye infection or inflammation, including the need of steroid eye drops
oKnown allergy to any of the IMPs
oThe use of contact lenses where the patient is not willing or able to uses glasses instead of contact lenses for the IMP treatment period.

5.Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. This includes any condition in which the IMP, the artificial tears used and/or systemic phenoxymethylpenicillin is contraindicated.
8.Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Study & Design

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