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Nasal PolypsPhase 3NCT05157412

Role of Doxycycline in Chronic Rhinosinusitis With Nasal Polyps

A Phase 3 study testing Doxycycline 100 mg Oral Tablet and Prednisolone 20 mg in people with Nasal Polyps and Chronic Rhinosinusitis With Nasal Polyps, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy of Doxycycline as an adjunct to systemic steroids in the treatment of chronic rhinosinusitis with nasal polyps Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Doxycycline 100 mg Oral Tablet and Prednisolone 20 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jul 2021to 1 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University Hospital

    Asyut, 71111

Other trials in Egypt

About this study

Official title: Role of Doxycycline in the Management of Patients With 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

Read the 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.

Being tested
Doxycycline 100 mg Oral Tablet, Prednisolone 20 mg
Medical subject headings
Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxycycline 100 mg Oral TabletDrug

    Also called doxycycline

    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 mgDrug

    Also called prednisolone

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

Study groups in NCT05157412
Study groupRoleWhat they receive
Steroids + DoxycyclineExperimentalSystemic 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.
Receives: Drug: Doxycycline 100 mg Oral Tablet; Drug: Prednisolone 20 mg
Steroids OnlyActive comparatorSystemic 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.
Receives: Drug: Prednisolone 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: after 12 weeks from the start of treatment

  2. 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

    Measured: after 12 weeks from the start of treatment

Secondary outcomes (2)

  1. 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.

    Measured: after 12 weeks from the start of treatment

  2. 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

    1. = mild symptoms
    2. = moderate symptoms
    3. = severe symptoms
    4. = 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.

    Measured: after 12 weeks from the start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2021
  2. Study start1 Jul 2021
  3. Primary completion1 Sep 2023
  4. Study completion1 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157412
Sponsor's protocol ID
Doxycycline in Nasal Polyps
Status last verified
Aug 2024
First submitted
25 Oct 2021
Last updated
13 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 20451040

  • 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.

    PubMed 16218510

  • 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.

    PubMed 32617061

  • 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.

  • 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.

    PubMed 16815148

  • 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.

    PubMed 15480349

  • 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.

    PubMed 8908275

  • 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.

    PubMed 7805431

  • 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.

    PubMed 12512904

  • 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.

    PubMed 18220943

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Doxycycline 100 mg Oral Tablet and Prednisolone 20 mg in people with Nasal Polyps and Chronic Rhinosinusitis With Nasal Polyps, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Polyp Size Score by Nasal Endoscopy (time frame: after 12 weeks from the start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05157412, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.

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