Role of Doxycycline in Chronic Rhinosinusitis With Nasal Polyps

NCT ID: NCT05157412

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-01-01

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.

Conditions

Nasal Polyps; Chronic Rhinosinusitis With Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Steroids + Doxycycline

Systemic Prednisolone in decreasing doses (40 mg/d on days 1-7, 20 mg/d on days 8-14, and 10 mg/d on days 15-21) along with Doxycycline (200 mg as a loading dose on the 1st day, followed by 100 mg once daily one hour before meal as a maintenance dose) for 3 weeks.

Group Type: EXPERIMENTAL

Doxycycline 100 mg Oral Tablet

Intervention Type: DRUG

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

Prednisolone 20 mg

Intervention Type: DRUG

Prednisolone will be used in both arms as a sole therapy in one and together with doxycycline in the other

Steroids Only

Systemic Prednisolone in decreasing doses (40 mg/d on days 1-7, 20 mg/d on days 8-14, and 10 mg/d on days 15-21) for 3 weeks.

Group Type: ACTIVE_COMPARATOR

Prednisolone 20 mg

Intervention Type: DRUG

Prednisolone will be used in both arms as a sole therapy in one and together with doxycycline in the other

Interventions

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

Intervention Type: DRUG

Prednisolone 20 mg

Prednisolone will be used in both arms as a sole therapy in one and together with doxycycline in the other

Intervention Type: DRUG

Other Intervention Names

doxycycline; prednisolone

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mai Essam Ali AbuElmagd

Residant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mai AbuElmagd

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Hamza El Shafie

Role: STUDY_DIRECTOR

Assiut University

Aly Ragaie

Role: STUDY_CHAIR

Assiut University

Locations

Assiut University Hospital

Asyut, , Egypt

Countries

Egypt

References

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Other Identifiers

Doxycycline in Nasal Polyps

Identifier Type: -

Identifier Source: org_study_id