NCT05157412

Role of Doxycycline in Chronic Rhinosinusitis With Nasal Polyps

Role of Doxycycline in the Management of Patients With Chronic Rhinosinusitis With Nasal Polyps

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of Doxycycline as an adjunct to systemic steroids in the treatment of chronic rhinosinusitis with nasal polyps

Detailed description

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a disease of the nose and paranasal sinuses characterized by mucosal thickening and polyp formation. The prevalence of CRSwNP in the general population ranges between 1 and 4%. It mostly affects adult individuals. The treatment of CRSwNP can include the use of steroids, antibiotics, saline nasal spray, mucolytics, topical/systemic decongestants, topical anticholinergics, anti-leukotrienes or receptor blockers, and antihistamines. Steroids have a multitude of effects, including inhibition of cytokine synthesis, reduction of the number of eosinophils and activated eosinophils, anti-oedema effects and reduction of transudation. Topical corticosteroid therapy is not effective in all patients, leading to the use of systemic glucocorticosteroids and/or sinus surgery to control the disease. As a new approach, antibiotics are being used to treat CRSwNP particularly in patients with disease exacerbated by the Staphylococcus aureus enterotoxin. Antibiotics with anti- inflammatory effects can be used to treat patients with chronic rhinosinusitis without polyps, which might be the precursor to CRSwNP. Long-term treatment with these drugs, in selected cases, may be effective when corticosteroids fail. Doxycycline has dual action: it has well described, broad-spectrum antibacterial activity against S aureus as well as anti-inflammatory properties. It appears to be effective in treatment of several chronic inflammatory airway diseases.

Conditions

• Nasal Polyps
• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DRUG	Doxycycline 100 mg Oral Tablet	Oral Doxycycline will be added to prednisolone as a comparison to using prednisolone as a sole therapy for the treatment of nasal polyps associated with chronic rhinosinusitis
DRUG	Prednisolone 20 mg	Prednisolone will be used in both arms as a sole therapy in one and together with doxycycline in the other

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-09-01
• Completion: 2024-01-01
• First posted: 2021-12-15
• Last updated: 2024-08-13

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study