Clinical trial NCT05157412: Role of Doxycycline in Chronic Rhinosinusitis With Nasal Polyps
Official title: Role of Doxycycline in the Management of Patients With Chronic Rhinosinusitis With Nasal Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1- Adult patients (aged 18 and over) with bilateral nasal polyps confirmed by nasal endoscopy and CT scan.

Exclusion Criteria:

1. CRS without nasal polyps.
2. Unilateral nasal polyps.
3. Pregnant and lactating women.
4. Patients younger than 18 years old.
5. Subjects with known allergic reaction to steroids or tetracyclines, hypertension, diabetes (type 1 and 2), glaucoma, tuberculosis, herpes infection are excluded.
6. If any major complications to the drugs in use appeared in process.

Primary outcomes:
measure: Polyp Size Score by Nasal Endoscopy
timeFrame: after 12 weeks from the start of treatment
measure: Radiological Evaluation
timeFrame: after 12 weeks from the start of treatment
Secondary outcomes:
measure: Laboratory Measures
timeFrame: after 12 weeks from the start of treatment
measure: Symptomatology
timeFrame: after 12 weeks from the start of treatment
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Mai AbuElmagd
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Hamza El Shafie
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Aly Ragaie
role: STUDY_CHAIR
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