Inhaled Steroids for Acute Pharyngitis.

NCT04027322 | Completed Phase 2 DMC

• 1 other identifier: OMSB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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 7 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.

Conditions

Acute Pharyngitis

Keywords

Pharyngitis; Sore Throat; Glucocorticoids; Nebulizers

Outcome Measures

Primary Outcomes (1)

• Number of participants with the complete resolution of sore throat after 24hours from intervention.

  Direct report by the patient of presence or absence of complete resolution of sore throat at 24 hours by telephone.

  24 hours after intervention.

Secondary Outcomes (6)

• Number of participants with the complete resolution of sore throat after 48 hours from intervention.

  48 hours after intervention.

• Number of hours needed until the onset of pain relief.

  7 days after intervention.

• Number of hours needed until complete resolution of sore throat.

  7 days after intervention.

• Average number of days of absences from work among participants.

  7 days after intervention.

• Number of participants reattended the Emergeancy Department (ED) due to acute pharyngitis.

  7 days after intervention.

Study Arms (3)

Budesonide

ACTIVE COMPARATOR

Drug Name: budesonide Dose: 2000mcg (2mg) of budesonide nebulizer solution is mixed with normal saline solution to make a total volume of 8mL. Frequency: Stat Dose Route: Nebulization

Drug: Budesonide 0.25 MG/ML Inhalant Solution

Dexamethasone

ACTIVE COMPARATOR

Drug Name: Dexamethasone Sodium phosphate Dose: 8mg of IV formula of dexamethasone is mixed with normal saline to make a total volume of 8ml. Frequency: Stat Dose Route: Nebulization

Drug: Dexamethasone

Control

PLACEBO COMPARATOR

Drug Name: Normal Saline Dose: 8ml. Frequency: Stat Dose Route: Nebulization

Drug: Normal saline

Interventions

Budesonide 0.25 MG/ML Inhalant Solution DRUG

Both medications used for the intervention groups are Glucocorticoids. The effect of glucocorticoids in AP can be attributed to their anti-inflammatory actions. They inhabit the formation of the pro-inflammatory mediators in the endothelial cells of the airways. This will decreases the inflammatory reaction at the pharynges which result in a reduction of throat pain. Studies have shown that the use of a single dose of systemic glucocorticoids for acute pharyngitis did not result in significant adverse events and no serious adverse events were reported (7) (8).

Budesonide

Dexamethasone DRUG

Both medications used for the intervention groups are Glucocorticoids. The effect of glucocorticoids in AP can be attributed to their anti-inflammatory actions. They inhabit the formation of the pro-inflammatory mediators in the endothelial cells of the airways. This will decreases the inflammatory reaction at the pharynges which result in a reduction of throat pain. Studies have shown that the use of a single dose of systemic glucocorticoids for acute pharyngitis did not result in significant adverse events and no serious adverse events were reported (7) (8).

Dexamethasone

Normal saline DRUG

Placebo for the control group.

Control

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Study Sites (3)

Armed Forces Hospital

Muscat, 113, Oman

Location

Mortaafah Armed Medical Hospital (MAM)

Muscat, 113, Oman

Location

Royal Oman Police Hospital

Muscat, 113, Oman

Location

Related Publications (10)

• Schappert SM, Rechtsteiner EA. Ambulatory medical care utilization estimates for 2006. Natl Health Stat Report. 2008 Aug 6;(8):1-29.

  PMID: 18958997 RESULT

• van Driel ML, De Sutter A, Deveugele M, Peersman W, Butler CC, De Meyere M, De Maeseneer J, Christiaens T. Are sore throat patients who hope for antibiotics actually asking for pain relief? Ann Fam Med. 2006 Nov-Dec;4(6):494-9. doi: 10.1370/afm.609.

  PMID: 17148626 RESULT

• Schachtel BP, Fillingim JM, Thoden WR, Lane AC, Baybutt RI. Sore throat pain in the evaluation of mild analgesics. Clin Pharmacol Ther. 1988 Dec;44(6):704-11. doi: 10.1038/clpt.1988.215.

  PMID: 3197368 RESULT

• Sadeghirad B, Siemieniuk RAC, Brignardello-Petersen R, Papola D, Lytvyn L, Vandvik PO, Merglen A, Guyatt GH, Agoritsas T. Corticosteroids for treatment of sore throat: systematic review and meta-analysis of randomised trials. BMJ. 2017 Sep 20;358:j3887. doi: 10.1136/bmj.j3887.

  PMID: 28931508 RESULT

• Hayward G, Thompson MJ, Perera R, Glasziou PP, Del Mar CB, Heneghan CJ. Corticosteroids as standalone or add-on treatment for sore throat. Cochrane Database Syst Rev. 2012 Oct 17;10:CD008268. doi: 10.1002/14651858.CD008268.pub2.

  PMID: 23076943 RESULT

• Hayward GN, Hay AD, Moore MV, Jawad S, Williams N, Voysey M, Cook J, Allen J, Thompson M, Little P, Perera R, Wolstenholme J, Harman K, Heneghan C. Effect of Oral Dexamethasone Without Immediate Antibiotics vs Placebo on Acute Sore Throat in Adults: A Randomized Clinical Trial. JAMA. 2017 Apr 18;317(15):1535-1543. doi: 10.1001/jama.2017.3417.

  PMID: 28418482 RESULT

• Atef K Salama, Ahmed M El-badawy. Does nebulized dexamethasone decrease the incidence of postextubation sore throat?: a randomized controlled study. Ains Shams J Anesthiology 9(1):104-7, 2016.

  RESULT

• Fitzgerald D, Mellis C, Johnson M, Allen H, Cooper P, Van Asperen P. Nebulized budesonide is as effective as nebulized adrenaline in moderately severe croup. Pediatrics. 1996 May;97(5):722-5.

  PMID: 8628614 RESULT

• Klassen TP, Feldman ME, Watters LK, Sutcliffe T, Rowe PC. Nebulized budesonide for children with mild-to-moderate croup. N Engl J Med. 1994 Aug 4;331(5):285-9. doi: 10.1056/NEJM199408043310501.

  PMID: 8022437 RESULT

• Al Atbi AY, Al Khalasi U, Al Atbi A, Al Rawahi S, Al Shaffi K, Al-Mamari S, Al Sakiti M, Al Mujani S, Al Reesi A, Al Shamsi M. Efficacy of nebulized glucocorticoids for acute pharyngitis in an emergency department outpatient population: a multicenter, double-blind, randomized clinical trial. CJEM. 2025 Jul;27(7):543-550. doi: 10.1007/s43678-025-00906-5. Epub 2025 Apr 24.

  PMID: 40272745 DERIVED

Related Links

• Wendy Stead. Symptomatic treatment of acute pharyngitis in adults. UPTODATE. 2018 \[cited 2019 Jan 7\].

MeSH Terms

Conditions

Pharyngitis

Interventions

Budesonide; Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Al Yaqdhan H Al Atbi, EM Resident. PGY 5

  Oman Medical Board Specialty (OMSB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Specialist

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 19, 2019
• Study Start: June 1, 2019
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

OM (3)