Role of Doxycycline in Chronic Rhinosinusitis With Nasal Polyps

NCT05157412 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: Doxycycline in Nasal Polyps
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasal Polyps; Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• 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. 1. = Small polyps in the middle meatus not reaching below the inferior border of the middle concha. 2. = Polyps reaching below the lower boarder of the middle turbinate. 3. = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha. 4. = Large polyps causing almost complete obstruction of the inferior meatus.

  after 12 weeks from the start of treatment

• 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 Outcomes (2)

• Laboratory Measures

  after 12 weeks from the start of treatment

• Symptomatology

  after 12 weeks from the start of treatment

Study Arms (2)

Steroids + Doxycycline

EXPERIMENTAL

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.

Drug: Doxycycline 100 mg Oral Tablet; Drug: Prednisolone 20 mg

Steroids Only

ACTIVE COMPARATOR

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.

Drug: Prednisolone 20 mg

Interventions

Doxycycline 100 mg Oral Tablet 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

Also known as: doxycycline

Steroids + Doxycycline

Prednisolone 20 mg DRUG

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

Also known as: prednisolone

Steroids + Doxycycline; Steroids Only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71111, Egypt

Location

Related Publications (10)

• 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.

  PMID: 20451040 BACKGROUND

• 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.

  PMID: 16218510 BACKGROUND

• 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.

  PMID: 32617061 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1016/j.jaci.2006.03.012. Epub 2006 May 19.

  PMID: 16815148 BACKGROUND

• 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. doi: 10.1016/j.jaci.2004.07.013. No abstract available.

  PMID: 15480349 BACKGROUND

• 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.

  PMID: 8908275 BACKGROUND

• 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. doi: 10.1159/000239310.

  PMID: 7805431 BACKGROUND

• 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.

  PMID: 12512904 BACKGROUND

• Rempe S, Hayden JM, Robbins RA, Hoyt JC. Tetracyclines and pulmonary inflammation. Endocr Metab Immune Disord Drug Targets. 2007 Dec;7(4):232-6. doi: 10.2174/187153007782794344.

  PMID: 18220943 BACKGROUND

MeSH Terms

Conditions

Nasal Polyps

Interventions

Doxycycline; Tablets; Prednisolone

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Mai AbuElmagd

  Assiut University

  PRINCIPAL INVESTIGATOR

• Hamza El Shafie

  Assiut University

  STUDY DIRECTOR

• Aly Ragaie

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residant

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: December 15, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

EG (1)