Inhaled Steroids for Acute Pharyngitis.

• Status: Unknown status
• Trial end date: 2020-08-30
• Target enrollment: 0
• Participant gender: All

Summary

Background: Acute pharyngitis (AP) is a common presentation to the Emergency Department (ED). Most AP patients' who present to the ED are interested in relief their sore throat (pain). There are different approaches available in the literature to control AP pain. Studies have shown that the use of systemic glucocorticoids significantly decreases patients' sore throat. Up to our knowledge, there are no available trials looking at the role of nebulized glucocorticoids in treating infective AP.

Aim: Our aim is to investigate in pediatrics and adults population ≥5 years presenting to ED with AP if the use of a single dose of nebulized glucocorticoids as an adjunct to standard AP treatment, compared with placebo leads to complete resolution or improvement in symptoms.

Method: The investigators are planning to conduct a multi-center, double-blind randomized control trial. There will be three arms; first arm: nebulized Budesonide, second arm: nebulized Dexamethasone and third arm: placebo nebulized Normal Saline (NS). The patients will be followed up for 15 days through phone calls to assess the primary and secondary outcomes. Our primary objective is to investigate whether the use of a single dose of nebulized glucocorticoids compared with placebo leads to significant improvement or complete resolution of the sore throat within 24hrs. Our secondary objectives are to assess if a single dose of glucocorticoids will: reduce sore throat at 48 hours, reduce absence from work or school, reduce the incidence of hospital admission, and reduce the rate of re-attendance to ED. Since there is no available data about the effect of nebulized glucocorticoids in AP, the appropriate sample size will be calculated after running a pilot study. The data will be recorded in the EpiData@ software. Then the data will be analyzed using the SPSS@ software. The ethical approval was sought from the ethical committee in each participating hospital and they approved it.

Results: The result of this study will be presented in local conferences as well in international conferences. The investigators will aim to publish the study in a well-known international emergency medicine journal.

Clinical application: up to our knowledge this study is the first study worldwide looking at the effect of nebulized glucocorticoids in patients with infective acute pharyngitis. As mentioned earlier that there are multiple approaches available in the literature to control sore throat pain and if our hypothesis turned to be correct then another alternative treatment can be added. The investigators believe that the use of topical route to administer glucocorticoids is more convenient for physicians and have less chance to develop adverse effect in comparison to systemic steroids.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oman Medical Speciality Board
• Treatments: BB 1101; Budesonide; Dexamethasone; Dexamethasone acetate; Glucocorticoids

Criteria

Inclusion Criteria:

• Pediatrics and adult > 5 years of age

• Patients complain of acute sore throat likely due to infective pharyngitis/tonsillitis as judged by the treating clinician.

• Onset of symptoms within 7 days

• Patient or caregiver has the capacity and willingness to give consent and complete the trial paperwork, including the symptom diary.

• Not on antibiotics for AP.

Exclusion Criteria:

• Pregnant or lactating mother.

• Recent use of oral or inhaled steroids within 7 days.

• Presence of an alternative diagnosis e.g. pneumonia, croup, bronchiolitis,

• Known immune-deficiency (e.g. HIV, active chemotherapy or advanced cancer)

• Complicated acute sore throat that hospital admission is required (e.g. completely unable to swallow, very systemically unwell, or peritonsillar abscess)

• Presence of clear contraindication for steroids use (refer to the British National Formulary (BNF) list of contraindications)

• Requirement for the live vaccine in the next 7 days.