Role of Doxycycline in Chronic Rhinosinusitis With Nasal Polyps

Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05157412
• Other study ID #: Doxycycline in Nasal Polyps
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: Mai AbuElmagd
• Phone: +201112550253
• Email: May.20134387[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

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
• Prednisolone 20 mg
Prednisolone will be used in both arms as a sole therapy in one and together with doxycycline in the other

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

Andrews AE, Bryson JM, Rowe-Jones JM. Site of origin of nasal polyps: relevance to pathogenesis and management. Rhinology. 2005 Sep;43(3):180-4. — View Citation

Hashiba M, Baba S. Efficacy of long-term administration of clarithromycin in the treatment of intractable chronic sinusitis. Acta Otolaryngol Suppl. 1996;525:73-8. — View Citation

Hissaria P, Smith W, Wormald PJ, Taylor J, Vadas M, Gillis D, Kette F. Short course of systemic corticosteroids in sinonasal polyposis: a double-blind, randomized, placebo-controlled trial with evaluation of outcome measures. J Allergy Clin Immunol. 2006 Jul;118(1):128-33. Epub 2006 May 19. — View Citation

Legent F, Bordure P, Beauvillain C, Berche P. A double-blind comparison of ciprofloxacin and amoxycillin/clavulanic acid in the treatment of chronic sinusitis. Chemotherapy. 1994;40 Suppl 1:8-15. — View Citation

Rempe S, Hayden JM, Robbins RA, Hoyt JC. Tetracyclines and pulmonary inflammation. Endocr Metab Immune Disord Drug Targets. 2007 Dec;7(4):232-6. Review. — View Citation

Stammberger H. Rhinoscopic surgery. In: Settipane GA, Lund VJ, Bernstein JM, Tos M, editor. Nasal polyps: epidemiology, patho- genesis and treatment. Rhode Island: Ocean Side Pub; 1997. p.7-15.

Subramanian HN, Schechtman KB, Hamilos DL. A retrospective analysis of treatment outcomes and time to relapse after intensive medical treatment for chronic sinusitis. Am J Rhinol. 2002 Nov-Dec;16(6):303-12. — View Citation

Tetik F, Korkut AY, Kaya KS, Ucak I, Celebi I, Coskun BU. Comparison of the Oral Steroids, Macrolides and Combination Therapy in Nasal Polyposis Patients. Sisli Etfal Hastan Tip Bul. 2020 Jun 12;54(2):211-217. doi: 10.14744/SEMB.2018.40316. eCollection 2020. — View Citation

Van Zele T, Gevaert P, Holtappels G, Beule A, Wormald PJ, Mayr S, Hens G, Hellings P, Ebbens FA, Fokkens W, Van Cauwenberge P, Bachert C. Oral steroids and doxycycline: two different approaches to treat nasal polyps. J Allergy Clin Immunol. 2010 May;125(5):1069-1076.e4. doi: 10.1016/j.jaci.2010.02.020. — View Citation

Van Zele T, Gevaert P, Watelet JB, Claeys G, Holtappels G, Claeys C, van Cauwenberge P, Bachert C. Staphylococcus aureus colonization and IgE antibody formation to enterotoxins is increased in nasal polyposis. J Allergy Clin Immunol. 2004 Oct;114(4):981-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polyp Size Score by Nasal Endoscopy	Every patient will undergo nasal endoscopy at the initial visit and every follow-up visit using a modified Lildholdt scoring system and given scores from 0 to 4. The total nasal polyp score is the sum of the scores from the right and left nostrils.; 0 = No polyps.; = Small polyps in the middle meatus not reaching below the inferior border of the middle concha.; = Polyps reaching below the lower boarder of the middle turbinate.; = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha.; = Large polyps causing almost complete obstruction of the inferior meatus.	after 12 weeks from the start of treatment
Primary	Radiological Evaluation	Multislice computed tomography scan of the nose and paranasal sinuses will be done before starting the treatment and at the end of the follow-up period (12 weeks) using the Lund-Mackay (LMK) scoring system where each sinus (maxillary, anterior ethmoidal, posterior ethmoidal, frontal, sphenoidal) is scored for opacification (0, no opacity; 1, partial opacity; 2, total opacity), and the osteo-meatal complex is scored 0 (no obstruction) or 2 (obstruction). The unilateral score goes from 0 to 12 whereas the bilateral score goes from 0 to 24	after 12 weeks from the start of treatment
Secondary	Laboratory Measures	Complete Blood count specifically the eosinophilic count (both relative and absolute) will be documented at the initial visit and at the end of treatment. Values of each group will be compared to each other.	after 12 weeks from the start of treatment
Secondary	Symptomatology	Using a questionnaire, all subjects will be asked to evaluate five symptoms (nasal obstruction, Rhinorrhea, postnasal discharge, hyposmia and facial pain) from 0 to 4.; 0 = no symptoms; = mild symptoms; = moderate symptoms; = severe symptoms; = very severe symptoms (intolerable) This will be assessed at the screening visit and follow-up visits at 3, 8 and 12 weeks as a sum of the five individual symptoms of a total score of 20.	after 12 weeks from the start of treatment