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NCT Number: NCT05157412

Role of Doxycycline in Chronic Rhinosinusitis With Nasal Polyps

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

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Key information

Conditions

Nasal Polyps Chronic Rhinosinusitis With Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assiut University Hospital

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: 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

Other names: prednisolone

Primary outcomes

  1. Polyp Size Score by Nasal Endoscopy

    Time frame: after 12 weeks from the start of treatment

    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.

  2. Radiological Evaluation

    Time frame: after 12 weeks from the start of treatment

    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

Secondary outcomes

  1. Laboratory Measures

    Time frame: after 12 weeks from the start of treatment

    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.

  2. Symptomatology

    Time frame: after 12 weeks from the start of treatment

    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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 15, 2021
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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