A study of flurbiprofen spray to reduce throat soreness in patients with upper respiratory tract infection.

Phase 3

Completed

• Conditions: Sore throat due to upper respiratory tract infection.; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12612000457842
• Lead Sponsor: ovotech (Australia) Pty Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

primary diagnosis: sore throat of onset within the past 4 days due to upper respiratory tract infection (URTI).
- sore throat (greater than or equal to 6) on the Throat Soreness Scale at baseline.
- objective findings confirm the presence of tonsillopharyngitis (greater than or equal to 5 points on the expanded 21-point Tonsillopharyngitis Assessment).
- must have greater than or equal to 50 mm on the Difficulty Swallowing Scale at Baseline
- must have greater than or equal to 33 mm on the Swollen Throat Scale at Baseline.
- written informed consent.

Exclusion Criteria

People with any of the following are unable to participate in the study:
1. previous history of allergy or known intolerance to the study drug or the following formulation constituents: xylitol, mannitol, carbomer 974P, sodium bicarbonate, mint, peppermint, aspartame, citric acid, silicon dioxide; or paracetamol or any excipients in the Paracetamol formulation; or aspirin or NSAID’s
2. sore throat present for more than 4 days.
3. evidence of mouth breathing or severe coughing.
4. gastric sensitivity to NSAID’s or a history of gastrointestinal bleeding or perforation, severe colitis, haemorrhagic or haematopoietic disorders related to previous NSAID therapy
5. active or history of recurrent peptic ulcer/haemorrhage or intestinal ulceration.
6. existing stomach ulcers or a history of stomach ulcers.
7. history of bronchospasm, rhinitis or urticaria associated with aspirin or NSAID’s.
8. uncontrolled asthma and those who have had an asthma attack in the last 8 weeks.
9. uncontrolled hypertension or severe heart failure.
10. systemic lupus erythmatosus or mixed connective tissue disease.
11. potential for abnormal bleeding.
12. any disease that can compromise breathing e.g. bronchopneumonia.
13. those who have:
- taken any medicated confectionary, throat pastille, spray, or any product with demulcent properties such as boiled sweets in the previous 2 hours.
- used any sore throat medication containing a local anaesthetic within the previous 4 hours.
- used any analgesic, antipyretic or cold medication (e.g. decongestant, antihistamine, antitussive or throat lozenge) within the previous 8 hours.
- used a longer acting or slow release analgesic during the previous 24 hours e.g. Piroxicam and Naproxen.
- taken antibiotics during the previous 14 days
- taken carbamezepine, phenobarbitone, phenytoin, primidone, rifampicin, St Johns Wort or other drugs that induce liver enzymes in the 14 days before enrolment into the study (i.e. before first dosing day).
14. those taking:
- NSAIDs including cyclooxygenase-2 selective inhibitors
- warfarin and other coumarins
15. any painful condition that may distract attention from sore throat pain e.g. mouth ulcers etc.
16. history of severe renal or hepatic impairment; or alcohol abuse or state that they regularly consume alcohol in excess of the recommended amounts (excessive alcohol >21 units per week for females and >28 units per week for males.).
17. are glutathione-deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
18. any painful condition that requires analgesic usage.
19. unable to refrain from smoking during their stay in the 20. women of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch or an intrauterine device).
21. previously randomised into the study; or have participated in a clinical trial in the previous 30 days.
22. unable in the opinion of the investigator to comply fully with the study requirements, e.g. such as those who cannot comprehend or correctly use thepain rating scales.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of throat soreness, assessed via the area under the change from baseline curve (AUC).<br>Throat soreness will be assessed using a 11-point ordinal scale (0-not sore, 10-very sore).[The 11-point ordinal scale for throat soreness will be assessed at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes (0-2 hours) after the first dose of study medication.]